New Drug Approvals Archive for 2016

Flucelvax Quadrivalent (influenza virus vaccine, inactivated)

Date of Approval: May 23, 2016
Company: Seqirus
Treatment for: Influenza Prophylaxis

Flucelvax Quadrivalent is an inactivated influenza vaccine indicated for active immunization for active immunization against influenza disease in people 2 years of age and older.

• FDA Approves Flucelvax - First Seasonal Influenza Vaccine Manufactured Using Cell Culture Technology
• Flucelvax Quadrivalent (influenza virus vaccine, inactivated) FDA Approval History

Flublok Quadrivalent (influenza virus vaccine, inactivated) Injection

Date of Approval: October 7, 2016
Company: Protein Sciences Corp.
Treatment for: Influenza Prophylaxis

FluBlok Quadrivalent is an influenza virus vaccine indicated for active immunization against seasonal influenza in adults 18 years of age and older .

• FDA Approves Flublok - New Seasonal Influenza Vaccine Made Using Novel Technology
• Flublok Quadrivalent (influenza virus vaccine, inactivated) FDA Approval History

Emverm (mebendazole) Chewable Tablets

Date of Approval: January 15, 2016
Company: Impax Laboratories, Inc.
Treatment for: Pinworm Infection, Whipworm Infection, Hookworm Infection, Ascariasis

Emverm (mebendazole) is a chewable tablet formulation of the approved anthelmintic mebendazole for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections.

• Impax Receives Approval of Emverm (mebendazole) Chewable Tablets
• Emverm (mebendazole) FDA Approval History

Adzenys XR-ODT (amphetamine) Extended-Release Orally Disintegrating Tablets

Date of Approval: January 27, 2016
Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit Hyperactivity Disorder (ADHD)

Adzenys XR-ODT (amphetamine) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

• Neos Therapeutics Announces FDA Approval of Adzenys XR-ODT (Amphetamine Extended-Release Orally Disintegrating Tablet) for ADHD
• Adzenys XR-ODT (amphetamine) FDA Approval History

Onzetra Xsail (sumatriptan) Inhalation Powder - formerly AVP-825

Date of Approval: January 27, 2016
Company: Avanir Pharmaceuticals, Inc.
Treatment for: Migraine

Onzetra Xsail (sumatriptan) is a fast-acting, intranasal serotonin 5-HT_1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura.

• FDA Approves Onzetra Xsail (sumatriptan nasal powder) for the Acute Treatment of Migraine
• Onzetra Xsail (sumatriptan) FDA Approval History

Zepatier (elbasvir and grazoprevir) Tablets

Date of Approval: January 28, 2016
Company: Merck & Co., Inc.
Treatment for: Hepatitis C

Zepatier (elbasvir and grazoprevir) is a once-daily, single tablet, NS5A replication complex inhibitor and NS3/4A protease inhibitor combination for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections.

• FDA Approves Zepatier (elbasvir and grazoprevir) for Chronic Hepatitis C Genotypes 1 and 4
• Zepatier (elbasvir and grazoprevir) FDA Approval History

Zembrace SymTouch (sumatriptan) Injection

Date of Approval: January 28, 2016
Company: Dr. Reddy’s Laboratories Ltd.
Treatment for: Migraine

Zembrace SymTouch (sumatriptan) is a selective 5-HT_1B/ID receptor agonist in a prefilled, ready-to-use, single-dose disposable autoinjector for the treatment of acute migraine episodes, with or without aura.

• Dr. Reddy’s Laboratories Ltd. Receives FDA Approval for Zembrace SymTouch (sumatriptan succinate) Injection for the Acute Treatment of Migraines
• Zembrace SymTouch (sumatriptan) FDA Approval History

Sernivo (betamethasone dipropionate) Topical Spray

Date of Approval: February 5, 2016
Company: Promius Pharma, LLC
Treatment for: Plaque Psoriasis

Sernivo Spray (betamethasone dipropionate) is a topical corticosteroid indicated for the treatment of mild to moderate plaque psoriasis.

• Promius Pharma Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray
• Sernivo (betamethasone dipropionate) FDA Approval History

Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution

Date of Approval: January 29, 2016
Company: Arbor Pharmaceuticals, LLC
Treatment for: Acetaminophen Overdose

Marketing Status: Discontinued

Cetylev (acetylcysteine) is an antidote for acetaminophen overdose indicated to prevent or lessen liver damage after the ingestion of a potentially hepatotoxic quantity of acetaminophen.

• Arbor Pharmaceuticals Announces FDA Approval of Cetylev
• Cetylev (acetylcysteine) FDA Approval History

Briviact (brivaracetam)

Date of Approval: February 19, 2016
Company: UCB, Inc.
Treatment for: Epilepsy

Briviact (brivaracetam) is a selective, high-affinity synaptic vesicle protein 2A ligand and analog of levetiracetam indicated for the treatment of partial-onset seizures in patients with epilepsy.

• FDA Approves Briviact (brivaracetam) to Treat Partial Onset Seizures
• Briviact (brivaracetam) FDA Approval History

Xeljanz XR (tofacitinib) Extended-Release Tablets

Date of Approval: February 23, 2016
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis

Xeljanz XR (tofacitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

• Pfizer Announces FDA Approval of Xeljanz XR (tofacitinib citrate), the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis
• Xeljanz XR (tofacitinib) FDA Approval History

Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) Tablets

Date of Approval: March 1, 2016
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) is a fixed-dose combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), indicated as a complete regimen for the treatment of HIV-1 infection.

• FDA Approves Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) for the Treatment of HIV-1 Infection
• Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) FDA Approval History

Idelvion (coagulation factor IX (recombinant), albumin fusion protein) Injection

Date of Approval: March 4, 2016
Company: CSL Behring
Treatment for: Hemophilia B

Idelvion (coagulation factor IX (recombinant), albumin fusion protein) is a long-acting recombinant human blood coagulation factor indicated for the control and prevention of bleeding episodes in patients with hemophilia B.

• FDA Approves Idelvion (coagulation factor IX (recombinant), albumin fusion protein) to Treat Patients with Hemophilia B
• Idelvion (coagulation factor IX (recombinant), albumin fusion protein) FDA Approval History

Evomela (melphalan) for Injection

Date of Approval: March 10, 2016
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma

Evomela (melphalan) is an alkylating agent used as a high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma (MM), and for the palliative treatment of patients with MM for whom oral therapy is not appropriate.

• FDA Grants Spectrum Pharmaceuticals Approval of Evomela (melphalan) for Injection
• Evomela (melphalan) FDA Approval History

Kovaltry (antihemophilic factor (recombinant)) Injection

Date of Approval: March 16, 2016
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Hemophilia A

Kovaltry (antihemophilic factor (recombinant)) is a human DNA sequence derived, full length Factor VIII concentrate indicated for the control and prevention of bleeding episodes in adults and children with hemophilia A.

• FDA Approves Bayer's Kovaltry (Antihemophilic Factor (Recombinant)) for the Treatment of Children and Adults with Hemophilia A
• Kovaltry (antihemophilic factor (recombinant)) FDA Approval History

Anthim (obiltoxaximab) Injection

Date of Approval: March 18, 2016
Company: Elusys Therapeutics, Inc.
Treatment for: Anthrax Prophylaxis, Anthrax

Anthim (obiltoxaximab) is a monoclonal antibody (mAb) anthrax antitoxin for the treatment and prevention of inhalational anthrax.

• FDA Approves Anthim (obiltoxaximab) for Inhalation Anthrax
• Anthim (obiltoxaximab) FDA Approval History

Taltz (ixekizumab) Injection

Date of Approval: March 22, 2016
Company: Eli Lilly and Company
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of:

• patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
• adults with active psoriatic arthritis.
• adults with active ankylosing spondylitis.
• adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

• FDA Approves Taltz (ixekizumab) for Plaque Psoriasis
• Taltz (ixekizumab) FDA Approval History

Cinqair (reslizumab) Injection

Date of Approval: March 23, 2016
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma

Cinqair (reslizumab) is an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with eosinophilic asthma.

• FDA Approves Cinqair (reslizumab) to Treat Severe Asthma
• Cinqair (reslizumab) FDA Approval History

Defitelio (defibrotide) Injection

Date of Approval: March 30, 2016
Company: Jazz Pharmaceuticals plc
Treatment for: Hepatic Veno-Occlusive Disease

Defitelio (defibrotide sodium) is a deoxyribonucleic acid derivative anticoagulant for the treatment of patients with hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).

• FDA Approves Defitelio (defibrotide sodium) for Hepatic Veno-Occlusive Disease Following Hematopoietic Stem-Cell Transplantation
• Defitelio (defibrotide) FDA Approval History

Descovy (emtricitabine and tenofovir alafenamide) Tablets

Date of Approval: April 4, 2016
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection, Pre-Exposure Prophylaxis of HIV

Descovy (emtricitabine and tenofovir alafenamide) is a nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination for the treatment of HIV-1 infection, and for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection.

• FDA Approves Descovy (emtricitabine and tenofovir alafenamide), Gilead’s Third TAF-Based HIV Therapy
• Descovy (emtricitabine and tenofovir alafenamide) FDA Approval History

Inflectra (infliximab-dyyb) Injection

Date of Approval: April 5, 2016
Company: Celltrion, Inc.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Inflectra (infliximab-dyyb) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

• FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade
• Inflectra (infliximab-dyyb) FDA Approval History

BromSite (bromfenac) Ophthalmic Solution

Date of Approval: April 8, 2016
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Postoperative Ocular Inflammation

BromSite (bromfenac) is a low dose nonsteroidal anti-inflammatory drug (NSAID) ophthalmic solution for the treatment of inflammation and prevention of pain in patients undergoing cataract surgery.

• Sun Pharma Receives FDA Approval For BromSite (bromfenac ophthalmic solution)
• BromSite (bromfenac) FDA Approval History

Venclexta (venetoclax) Tablets

Date of Approval: April 11, 2016
Company: AbbVie Inc.
Treatment for: Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor indicated:

• for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
• in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

• FDA Approves Venclexta (venetoclax) for Chronic Lymphocytic Leukemia with 17p Deletion
• Venclexta (venetoclax) FDA Approval History

Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) Inhalation Aerosol

Date of Approval: April 25, 2016
Company: AstraZeneca Pharmaceuticals LP
Treatment for: COPD

Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) is a long -acting beta₂-adrenergic agonist (LABA) and anticholinergic combination indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

• Bevespi Aerosphere Approved by the FDA for Patients with COPD
• Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) FDA Approval History

Cabometyx (cabozantinib) Tablets

Date of Approval: April 25, 2016
Company: Exelixis, Inc.
Treatment for: Renal Cell Carcinoma, Hepatocellular Carcinoma, Thyroid Cancer, Neuroendocrine Tumors

Cabometyx (cabozantinib) is a tyrosine kinase inhibitor used for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, differentiated thyroid cancer, and neuroendocrine tumors.

• Exelixis Announces FDA Approval of Cabometyx (cabozantinib) for Patients with Advanced Renal Cell Carcinoma
• Cabometyx (cabozantinib) FDA Approval History

Xtampza ER (oxycodone) Extended-Release Capsules

Date of Approval: April 26, 2016
Company: Collegium Pharmaceutical, Inc.
Treatment for: Chronic Pain

Xtampza ER (oxycodone) is an extended-release, abuse-deterrent, narcotic analgesic for the treatment of chronic pain.

• Collegium Receives FDA Approval for Xtampza ER, an Analgesic with Abuse-Deterrent Properties
• Xtampza ER (oxycodone) FDA Approval History

Nuplazid (pimavanserin) Tablets and Capsules

Date of Approval: April 29, 2016
Company: Acadia Pharmaceuticals Inc.
Treatment for: Parkinson’s Disease Psychosis

Nuplazid (pimavanserin) is a non-dopaminergic, selective serotonin inverse agonist (SSIA) for the treatment of psychosis associated with Parkinson’s disease.

• FDA Approves Nuplazid (pimavanserin) for Parkinson’s Disease Psychosis
• Nuplazid (pimavanserin) FDA Approval History

Akovaz (ephedrine sulfate) Injection

Date of Approval: April 29, 2016
Company: Flamel Technologies
Treatment for: Hypotension

Akovaz (ephedrine sulfate) is a pressor agent administered parenterally to address clinically important hypotension in surgical settings.

• Flamel Technologies Receives FDA Approval of Akovaz (ephedrine sulfate) for Surgical Hypotension
• Akovaz (ephedrine sulfate) FDA Approval History

Ameluz (aminolevulinic acid) Gel - formerly BF-200 ALA

Date of Approval: May 10, 2016
Company: Biofrontera Inc.
Treatment for: Actinic Keratosis

Ameluz (aminolevulinic acid) is a porphyrin precursor used in combination with the BF-RhodoLED lamp for photodynamic therapy (PDT) treatment of actinic keratoses on the face and scalp.

• Biofrontera Announces U.S. FDA Approval of Ameluz and Activating BF-RhodoLED Device for Treatment of Actinic Keratosis
• Ameluz (aminolevulinic acid) FDA Approval History

Tecentriq (atezolizumab) Injection

Date of Approval: May 18, 2016
Company: Genentech, Inc.
Treatment for: Non Small Cell Lung Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma, Melanoma, Alveolar Soft Part Sarcoma

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for use in the treatment of non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), heptatocellular carcinoma, melanoma, and alveolar soft part sarcoma.

• FDA Approves Tecentriq (atezolizumab) for Urothelial Carcinoma
• Tecentriq (atezolizumab) FDA Approval History

Flucelvax Quadrivalent (influenza virus vaccine, inactivated)

Date of Approval: May 23, 2016
Company: Seqirus
Treatment for: Influenza Prophylaxis

Flucelvax Quadrivalent is an inactivated influenza vaccine indicated for active immunization for active immunization against influenza disease in people 2 years of age and older.

• Seqirus Receives FDA Approval for Flucelvax Quadrivalent (Influenza Vaccine) for People Four Years of Age and Older
• Flucelvax Quadrivalent (influenza virus vaccine, inactivated) FDA Approval History

Afstyla (antihemophilic factor (recombinant), single chain) for Injection

Date of Approval: May 25, 2016
Company: CSL Behring
Treatment for: Hemophilia A

Afstyla (antihemophilic factor (recombinant), single chain, is a recombinant, antihemophilic factor indicated for the control and prevention of bleeding episodes in adults and children with hemophilia A.

• FDA Approves Afstyla (Antihemophilic Factor (Recombinant), Single Chain) for Hemophilia A
• Afstyla (antihemophilic factor (recombinant), single chain) FDA Approval History

Probuphine (buprenorphine) Implant

Date of Approval: May 26, 2016
Company: Titan Pharmaceuticals, Inc.
Treatment for: Opioid Use Disorder

Probuphine (buprenorphine) is an opioid partial agonist subdermal implant for the treatment of opioid dependence.

• FDA Approves Probuphine (buprenorphine) Implant for Treatment of Opioid Dependence
• Probuphine (buprenorphine) FDA Approval History

Ocaliva (obeticholic acid) Tablets

Date of Approval: May 27, 2016
Company: Intercept Pharmaceuticals, Inc.
Treatment for: Primary Biliary Cholangitis

Ocaliva (obeticholic acid) is a first-in-class farnesoid X receptor (FXR) agonist for the treatment of primary biliary cholangitis.

• FDA Grants Accelerated Approval to Ocaliva (obeticholic acid) for Primary Biliary Cholangitis
• Ocaliva (obeticholic acid) FDA Approval History

Axumin (fluciclovine F 18) Injection

Date of Approval: May 27, 2016
Company: Blue Earth Diagnostics, Ltd.
Treatment for: Diagnosis and Investigation

Axumin (fluciclovine F 18) a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected recurrent prostate cancer.

• FDA Approves Axumin (fluciclovine F 18) Diagnostic Imaging Agent to Detect Recurrent Prostate Cancer
• Axumin (fluciclovine F 18) FDA Approval History

Zinbryta (daclizumab) Injection

Date of Approval: May 27, 2016
Company: AbbVie, Inc. and Biogen
Treatment for: Multiple Sclerosis

Zinbryta (daclizumab) is an interleukin-2 receptor blocking antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS).

• FDA Approves Zinbryta (daclizumab) to Treat Multiple Sclerosis
• Zinbryta (daclizumab) FDA Approval History

Netspot (gallium Ga 68 dotatate) Injection

Date of Approval: June 1, 2016
Company: Advanced Accelerator Applications USA, Inc.
Treatment for: Diagnosis and Investigation

Netspot (gallium Ga 68 dotatate) is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors

• FDA Approves Netspot (gallium Ga 68 dotatate) Imaging Agent to Detect Rare Neuroendocrine Tumors
• Netspot (gallium Ga 68 dotatate) FDA Approval History

Byvalson (nebivolol and valsartan) Tablets

Date of Approval: June 3, 2016
Company: AbbVie Inc.
Treatment for: High Blood Pressure

Byvalson (nebivolol and valsartan) is a beta adrenergic blocker and an angiotensin II receptor blocker (ARB) fixed dose combination indicated for the treatment of hypertension.

• Allergan Announces FDA Approval of Byvalson (nebivolol and valsartan) for Hypertension
• Byvalson (nebivolol and valsartan) FDA Approval History

Vaxchora (cholera vaccine, live, oral) Suspension for Oral Administration

Date of Approval: June 10, 2016
Company: Emergent BioSolutions, Inc.
Treatment for: Cholera Prophylaxis

Vaxchora (cholera vaccine, live, oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults traveling to cholera-affected areas.

• FDA Approves Vaxchora (Cholera Vaccine, Live, Oral) to Prevent Cholera in Travelers
• Vaxchora (cholera vaccine, live, oral) FDA Approval History

GoNitro (nitroglycerin) Sublingual Powder

Date of Approval: June 8, 2016
Company: Espero Pharmaceuticals, Inc.
Treatment for: Angina Pectoris Prophylaxis

GoNitro (nitroglycerin) is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

• Espero Pharmaceuticals Receives FDA Approval for GoNitro (nitroglycerin) Sublingual Powder
• GoNitro (nitroglycerin) FDA Approval History

Rayaldee (calcifediol) Extended Release Capsules

Date of Approval: June 17, 2016
Company: OPKO Health, Inc.
Treatment for: Secondary Hyperparathyroidism

Rayaldee (calcifediol) is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism associated with vitamin D Insufficiency in stage 3-4 chronic kidney disease.

• FDA Approves Rayaldee (calcifediol) to Treat Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease
• Rayaldee (calcifediol) FDA Approval History

Epclusa (sofosbuvir and velpatasvir) Tablets and Oral Pellets

Date of Approval: June 28, 2016
Company: Gilead Sciences, Inc.
Treatment for: Hepatitis C

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

• FDA Approves Epclusa (sofosbuvir and velpatasvir) for Treatment of all Major Forms of Chronic Hepatitis C Virus Infection
• Epclusa (sofosbuvir and velpatasvir) FDA Approval History

Syndros (dronabinol) Oral Solution

Date of Approval: July 1, 2016
Company: Insys Therapeutics, Inc.
Treatment for: Anorexia -- AIDS Patients; Nausea/Vomiting -- Chemotherapy Induced

Syndros (dronabinol) is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (THC) approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

• Insys Therapeutics Announces FDA Approval of Syndros (dronabinol) Oral Solution
• Syndros (dronabinol) FDA Approval History

Kovanaze (oxymetazoline hydrochloride and tetracaine hydrochloride) Nasal Spray

Date of Approval: June 29, 2016
Company: St. Renatus, LLC
Treatment for: Dental Anesthesia

Kovanaze (oxymetazoline hydrochloride and tetracaine hydrochloride) is a vasoconstrictor and local anesthetic combination administered intranasally as a topical anesthetic for use in restorative dental procedures.

• St. Renatus, LLC Announces FDA Approval of Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray for Use in Dentistry
• Kovanaze (oxymetazoline hydrochloride and tetracaine hydrochloride) FDA Approval History

Xiidra (lifitegrast) Ophthalmic Solution

Date of Approval: July 11, 2016
Company: Shire US Inc.
Treatment for: Dry Eye Disease

Xiidra (lifitegrast) is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease.

• FDA Approves Xiidra (lifitegrast ophthalmic solution) for Dry Eye Disease
• Xiidra (lifitegrast) FDA Approval History

Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) Extended-Release Tablets

Date of Approval: July 22, 2016
Company: Abbvie, Inc.
Treatment for: Hepatitis C

Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) is a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, NS5A inhibitor, NS3/4A protease inhibitor, and CYP3A inhibitor fixed-dose combination indicated for the once-daily treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1 infection.

• AbbVie Receives U.S. FDA Approval of Once-Daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C
• Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) FDA Approval History

Adlyxin (lixisenatide) Injection

Date of Approval: July 27, 2016
Company: Sanofi
Treatment for: Type 2 Diabetes

Adlyxin (lixisenatide) is a once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus.

• Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes
• Adlyxin (lixisenatide) FDA Approval History

Qbrelis (lisinopril) Oral Solution

Date of Approval: July 29, 2016
Company: Azurity Pharmaceuticals, Inc.
Treatment for: High Blood Pressure, Heart Failure, Heart Attack

Qbrelis (lisinopril) is an oral solution formulation of the approved angiotensin converting enzyme (ACE) inhibitor lisinopril indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults.

• FDA Approves Qbrelis (lisinopril) Oral Solution for Pediatric Patients 6 Years of Age and Older
• Qbrelis (lisinopril) FDA Approval History

Flonase Sensimist (fluticasone furoate) Nasal Spray

Date of Approval: August 2, 2016
Company: GSK Consumer Healthcare
Treatment for: Allergic Rhinitis

Flonase Sensimist (fluticasone furoate) is an over-the-counter corticosteroid nasal spray indicated for the treatment of symptoms associated with seasonal and perennial allergies in adults and children ages 2 years and older.

• FDA Approves Flonase Sensimist Allergy Relief
• Flonase Sensimist (fluticasone furoate) FDA Approval History

Sustol (granisetron) Extended-Release Injection

Date of Approval: August 9, 2016
Company: Heron Therapeutics, Inc.
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Sustol (granisetron) is a long-acting 5-HT3 antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

• Heron Therapeutics Announces FDA Approval of Sustol (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
• Sustol (granisetron) FDA Approval History

Troxyca ER (naltrexone and oxycodone) Extended-Release Capsules

Date of Approval: August 19, 2016
Company: Pfizer Inc.
Treatment for: Pain

Marketing Status: Discontinued

Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) is an extended-release, abuse-deterrent, narcotic analgesic formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

• FDA Approves Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) Capsules with Abuse-Deterrent Properties for the Management of Pain
• Troxyca ER (naltrexone and oxycodone) FDA Approval History

Otovel (ciprofloxacin and fluocinolone acetonide) Otic Solution

Date of Approval: April 29, 2016
Company: Laboratorios Salvat S.A. and Arbor Pharmaceuticals, LLC
Treatment for: Acute Otitis Media with Tympanostomy Tubes

Otovel otic solution (ciprofloxacin and fluocinolone acetonide) is a fluoroquinolone antibacterial and corticosteroid combination indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients.

• Laboratorios Salvat S.A. and Arbor Pharmaceuticals, LLC Announce the Launch of Otovel (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) Otic Solution
• Otovel (ciprofloxacin and fluocinolone acetonide) FDA Approval History

Afluria Quadrivalent (influenza virus vaccine, inactivated) Injection

Date of Approval: August 26, 2016
Company: Seqirus
Treatment for: Influenza Prophylaxis

Afluria Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in persons 6 months of age and older.

• Seqirus Receives FDA Approval for Afluria Quadrivalent (Influenza Vaccine) for People 18 Years of Age and Older
• Afluria Quadrivalent (influenza virus vaccine, inactivated) FDA Approval History

Erelzi (etanercept-szzs) Injection

Date of Approval: August 30, 2016
Company: Sandoz Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis

Erelzi (etanercept-szzs) is a tumor necrosis factor (TNF) blocker biosimilar to Enbrel indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

• FDA Approves Erelzi (etanercept-szzs), a Biosimilar to Enbrel
• Erelzi (etanercept-szzs) FDA Approval History

Cuvitru (immune globulin subcutaneous (human)) Injection

Date of Approval: September 13, 2016
Company: Shire plc
Treatment for: Primary Immunodeficiency Syndrome

Cuvitru (immune globulin subcutaneous (human)) is indicated as replacement therapy in the treatment of primary humoral immunodeficiency (PI).

• Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency
• Cuvitru (immune globulin subcutaneous (human)) FDA Approval History

Yosprala (aspirin and omeprazole) Delayed-Release Tablets

Date of Approval: September 14, 2016
Company: Aralez Pharmaceuticals Inc.
Treatment for: Ischemic Stroke, Prophylaxis, Gastric Ulcer Prophylaxis

Yosprala (aspirin and omeprazole) is a platelet aggregation inhibitor and proton pump inhibitor combination indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.

• FDA Approves Yosprala (aspirin and omeprazole) for Secondary Prevention of Cardiovascular Disease in Patients at Risk for Aspirin-Associated Gastric Ulcers
• Yosprala (aspirin and omeprazole) FDA Approval History

Exondys 51 (eteplirsen) Injection

Date of Approval: September 19, 2016
Company: Sarepta Therapeutics
Treatment for: Duchenne Muscular Dystrophy

Exondys 51 (eteplirsen) is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

• FDA Approves Exondys 51 (eteplirsen) for Duchenne Muscular Dystrophy
• Exondys 51 (eteplirsen) FDA Approval History

Kyleena (levonorgestrel) Releasing Intrauterine System

Date of Approval: September 16, 2016
Company: Bayer
Treatment for: Birth Control

Kyleena (levonorgestrel-releasing intrauterine system) is a low-dose progestin-containing intrauterine system (IUS) indicated for the prevention of pregnancy for up to five years.

• FDA Approves Bayer's Kyleena (Levonorgestrel-Releasing Intrauterine System) for Prevention of Pregnancy for up to Five Years
• Kyleena (levonorgestrel) FDA Approval History

Lomaira (phentermine hydrochloride) Tablets

Date of Approval: September 13, 2016
Company: KVK Tech, Inc.
Treatment for: Weight Loss (Obesity/Overweight), Weight Loss (Obesity/Overweight)

Lomaira (phentermine hydrochloride) is a sympathomimetic amine anorectic used short-term for weight reduction in overweight or obese adults.

• KVK Tech Announces FDA-Approval of Lomaira (phentermine hydrochloride USP) for Weight Reduction
• Lomaira (phentermine hydrochloride) FDA Approval History

Amjevita (adalimumab-atto) Injection

Date of Approval: September 23, 2016
Company: Amgen Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Amjevita (adalimumab-atto) an anti-TNF-α monoclonal antibody biosimilar/interchangeable to Humira indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

• FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira
• Amjevita (adalimumab-atto) FDA Approval History

Carnexiv (carbamazepine) Injection

Date of Approval: October 7, 2016
Company: Lundbeck Inc.
Treatment for: Seizures

Marketing Status: Discontinued

Carnexiv (carbamazepine) is an intravenous injection formulation of the antiepileptic drug carbamazepine indicated as short-term replacement therapy for oral carbamazepine when oral administration is temporarily not feasible.

• FDA Approves Carnexiv (carbamazepine) injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types
• Carnexiv (carbamazepine) FDA Approval History

Lartruvo (olaratumab) Injection

Date of Approval: October 19, 2016
Company: Eli Lilly and Company
Treatment for: Soft Tissue Sarcoma

Lartruvo (olaratumab) is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody indicated in combination with doxorubicin for the treatment of patients with advanced soft tissue sarcoma (STS).

• FDA Grants Accelerated Approval to Lartruvo (olaratumab) for Advanced Soft Tissue Sarcoma
• Lartruvo (olaratumab) FDA Approval History

Zinplava (bezlotoxumab) Injection

Date of Approval: October 21, 2016
Company: Merck & Co., Inc.
Treatment for: Prevention of <i>Clostridium Difficile</i> Infection Recurrence

Zinplava (bezlotoxumab) is a selective, fully-human, monoclonal antibody that binds to Clostridium difficile toxin B, indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older.

• FDA Approves Merck’s Zinplava (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection
• Zinplava (bezlotoxumab) FDA Approval History

Vemlidy (tenofovir alafenamide) Tablets

Date of Approval: November 10, 2016
Company: Gilead Sciences, Inc.
Treatment for: Hepatitis B

Vemlidy (tenofovir alafenamide) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.

• FDA Approves Gilead’s Vemlidy (tenofovir alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection
• Vemlidy (tenofovir alafenamide) FDA Approval History

Intrarosa (prasterone) Vaginal Inserts

Date of Approval: November 17, 2016
Company: Endoceutics Inc.
Treatment for: Dyspareunia

Intrarosa (prasterone) is a once-daily, vaginally administered steroid indicated to treat postmenopausal women experiencing moderate to severe pain during sexual intercourse (dyspareunia) as a symptom of vulvar and vaginal atrophy.

• FDA Approves Intrarosa (prasterone) for Postmenopausal Women Experiencing Dyspareunia
• Intrarosa (prasterone) FDA Approval History

Xultophy (insulin degludec and liraglutide) Injection - formerly IDegLira

Date of Approval: November 21, 2016
Company: Novo Nordisk
Treatment for: Type 2 Diabetes

Xultophy 100/3.6 (insulin degludec and liraglutide) is a fixed-ratio combination of the long-acting basal insulin analog, insulin degludec (Tresiba), and the a glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Victoza), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

• Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 Diabetes
• Xultophy (insulin degludec and liraglutide) FDA Approval History

Soliqua 100/33 (insulin glargine and lixisenatide) Injection

Date of Approval: November 21, 2016
Company: Sanofi
Treatment for: Type 2 Diabetes

Soliqua 100/33 (insulin glargine and lixisenatide) is fixed-ratio combination of the long-acting human insulin analog insulin glargine (Lantus) and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Adlyxin), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

• Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes
• Soliqua 100/33 (insulin glargine and lixisenatide) FDA Approval History

Eucrisa (crisaborole) Topical Ointment

Date of Approval: December 14, 2016
Company: Pfizer, Inc.
Treatment for: Atopic Dermatitis

Eucrisa (crisaborole) is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.

• FDA Approves Eucrisa (crisaborole) for Eczema
• Eucrisa (crisaborole) FDA Approval History

Rubraca (rucaparib) Tablets

Date of Approval: December 19, 2016
Company: Clovis Oncology, Inc.
Treatment for: Ovarian Cancer, Prostate Cancer

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of ovarian cancer and prostate cancer.

• FDA Grants Accelerated Approval to Rubraca (rucaparib) for Advanced Ovarian Cancer
• Rubraca (rucaparib) FDA Approval History

Spinraza (nusinersen) Injection

Date of Approval: December 23, 2016
Company: Biogen
Treatment for: Spinal Muscular Atrophy

Spinraza (nusinersen) is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

• FDA Approves Spinraza (nusinersen) for Spinal Muscular Atrophy
• Spinraza (nusinersen) FDA Approval History

Tirosint-SOL (levothyroxine sodium) Oral Solution

Date of Approval: December 15, 2016
Company: Institut Biochimique SA
Treatment for: Underactive Thyroid, TSH Suppression

Tirosint-SOL is an oral liquid formulation of levothyroxine (T4) for the treatment of hypothyroidism and for pituitary thyrotropin (thyroid stimulating hormone, TSH) suppression.

• FDA Approves Tirosint-SOL (levothyroxine sodium) Oral Solution for Hypothyroidism and Pituitary Thyrotropin Suppression
• Tirosint-SOL (levothyroxine sodium) FDA Approval History

Afluria Quadrivalent (influenza virus vaccine, inactivated) Injection

Date of Approval: August 26, 2016
Company: Seqirus
Treatment for: Influenza Prophylaxis

Afluria Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in persons 6 months of age and older.

• Seqirus Receives FDA Approval of Afluria Quadrivalent (Influenza Vaccine) for People Five Years of Age and Older in the U.S.
• Afluria Quadrivalent (influenza virus vaccine, inactivated) FDA Approval History