New Drug Approvals Archive for 2013

FluLaval Quadrivalent (influenza virus vaccine, inactivated)

Date of Approval: August 16, 2013
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis

FluLaval Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in people aged 6 months and older.

• FDA Approves FluLaval for Upcoming Influenza Season
• FluLaval Quadrivalent (influenza virus vaccine, inactivated) FDA Approval History

Skyla (levonorgestrel) Intrauterine System

Date of Approval: January 9, 2013
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Birth Control

Skyla (levonorgestrel) is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to three years.

• U.S. FDA Approves Bayer's Skyla (Levonorgestrel-Releasing Intrauterine System) 13.5 mg For Prevention Of Pregnancy For Up To Three Years
• Skyla (levonorgestrel) FDA Approval History

Uceris (budesonide)

Date of Approval: January 14, 2013
Company: Santarus, Inc.
Treatment for: Ulcerative Colitis

Uceris (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

• Santarus Receives FDA Approval of Uceris (budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis
• Uceris (budesonide) FDA Approval History

Octaplas (pooled plasma (human)) Solution for Intravenous Infusion

Date of Approval: January 17, 2013
Company: Octapharma
Treatment for: Bleeding Disorder

Octaplas is a solvent/detergent (S/D) treated, pooled human plasma indicated for the replacement of multiple coagulation factors in patients with acquired deficiencies and plasma exchange in patients with thrombotic thrombocytopenic purpura.

• FDA Approves Octaplas to Treat Patients with Blood Clotting Disorders
• Octaplas (pooled plasma (human)) FDA Approval History

Zecuity (sumatriptan) Transdermal Patch

Date of Approval: January 17, 2013
Company: NuPathe Inc.
Treatment for: Migraine

Marketing Status: Discontinued

Zecuity (sumatriptan iontophoretic transdermal system) is a serotonin (5HT) 1b/1d receptor agonist (triptan) indicated for the acute treatment of migraine.

• NuPathe's Zecuity Approved by the FDA for the Acute Treatment of Migraine
• Zecuity (sumatriptan) FDA Approval History

Oxytrol for Women (oxybutynin) Transdermal System

Date of Approval: January 25, 2013
Company: Allergan, Inc.
Treatment for: Overactive Bladder

Oxytrol for Women (oxybutynin) is a muscarinic receptor antagonist transdermal patch available over-the-counter for the treatment of overactive bladder in women.

• FDA Approves Over-the-Counter Oxytrol for Women to treat Overactive Bladder
• Oxytrol for Women (oxybutynin) FDA Approval History

Nesina (alogliptin) Tablets - formerly SYR-322

Date of Approval: January 25, 2013
Company: Takeda Pharmaceutical Company Limited
Treatment for: Type 2 Diabetes

Nesina (alogliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes.

• Takeda Receives FDA Approval for Nesina (alogliptin) for Type 2 Diabetes
• Nesina (alogliptin) FDA Approval History

Oseni (alogliptin and pioglitazone) Tablets - formerly SYR-322/Actos

Date of Approval: January 25, 2013
Company: Takeda Pharmaceutical Company Limited
Treatment for: Type 2 Diabetes

Oseni (alogliptin and pioglitazone) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione fixed-dose combination for the treatment of type 2 diabetes.

• Takeda Receives FDA Approval for Oseni (alogliptin and pioglitazone) for Type 2 Diabetes
• Oseni (alogliptin and pioglitazone) FDA Approval History

Kazano (alogliptin and metformin) Tablets

Date of Approval: January 25, 2013
Company: Takeda Pharmaceutical Company Limited
Treatment for: Type 2 Diabetes

Kazano (alogliptin and metformin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide antihyperglycemic fixed-dose combination for the treatment of type 2 diabetes.

• Takeda Receives FDA Approval for Kazano (alogliptin and metformin) for Type 2 Diabetes
• Kazano (alogliptin and metformin) FDA Approval History

Kynamro (mipomersen) Injection

Date of Approval: January 29, 2013
Company: Kastle Therapeutics
Treatment for: High Cholesterol, Familial Homozygous

Marketing Status: Discontinued

Kynamro (mipomersen) is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis indicated for the treatment of patients with homozygous familial hypercholesterolemia.

• FDA Approves New Orphan Drug Kynamro to Treat Inherited Cholesterol Disorder
• Kynamro (mipomersen) FDA Approval History

Ravicti (glycerol phenylbutyrate) Oral Liquid

Date of Approval: February 1, 2013
Company: Hyperion Therapeutics
Treatment for: Urea Cycle Disorders

Ravicti (glycerol phenylbutyrate) is a nitrogen-binding agent for the chronic management of patients with urea cycle disorders.

• FDA Approves Ravicti for the Chronic Management of Some Urea Cycle Disorders
• Ravicti (glycerol phenylbutyrate) FDA Approval History

Delzicol (mesalamine) Delayed-Release Capsules

Date of Approval: February 1, 2013
Company: AbbVie Inc.
Treatment for: Ulcerative Colitis

Delzicol (mesalamine) is an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

• Warner Chilcott Announces FDA Approval of New Ulcerative Colitis Product Delzicol
• Delzicol (mesalamine) FDA Approval History

Pomalyst (pomalidomide) Capsules

Date of Approval: February 8, 2013
Company: Bristol Myers Squibb
Treatment for: Multiple Myeloma, Kaposi's Sarcoma

Pomalyst (pomalidomide) is a thalidomide analogue used for the treatment of multiple myeloma, and AIDS-related and HIV-negative Kaposi sarcoma.

• FDA Approves Pomalyst for Advanced Multiple Myeloma
• Pomalyst (pomalidomide) FDA Approval History

Kadcyla (ado-trastuzumab emtansine) Injection

Date of Approval: February 22, 2013
Company: Genentech, Inc.
Treatment for: Breast Cancer

Kadcyla (ado-trastuzumab emtansine) is a HER2-targeted antibody and microtubule inhibitor conjugate indicated for the treatment of patients with HER2-positive, metastatic breast cancer.

• FDA Approves Kadcyla for Late-Stage Breast Cancer
• Kadcyla (ado-trastuzumab emtansine) FDA Approval History

Osphena (ospemifene) Tablets

Date of Approval: February 26, 2013
Company: Duchesnay Inc.
Treatment for: Dyspareunia, Atrophic Vaginitis

Osphena (ospemifene) is an estrogen agonist/antagonist indicated for the treatment of symptoms of vulvar and vaginal atrophy due to menopause, including severe dyspareunia and moderate to severe vaginal dryness.

• FDA Approves Osphena for Postmenopausal Women Experiencing Dyspareunia
• Osphena (ospemifene) FDA Approval History

Vituz (chlorpheniramine and hydrocodone) Oral Solution

Date of Approval: February 20, 2013
Company: Hawthorn Pharmaceuticals, Inc.
Treatment for: Cough, Cold Symptoms

Vituz (chlorpheniramine and hydrocodone) Oral Solution is an antihistamine/antitussive combination indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold.

• Pernix Therapeutics Receives FDA Approval for Vituz
• Vituz (chlorpheniramine and hydrocodone) FDA Approval History

Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension

Date of Approval: February 28, 2013
Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
Treatment for: Schizophrenia, Bipolar Disorder

Abilify Maintena (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia, and maintenance monotherapy treatment of bipolar I disorder.

• FDA Approves Once-Monthly Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia
• Abilify Maintena (aripiprazole) FDA Approval History

Lymphoseek (technetium Tc 99m tilmanocept) Injection

Date of Approval: March 13, 2013
Company: Navidea Biopharmaceuticals
Treatment for: Diagnosis and Investigation

• Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management.
• Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

• FDA Approves Lymphoseek to Help Locate Lymph Nodes in Patients with Certain Cancers
• Lymphoseek (technetium Tc 99m tilmanocept) FDA Approval History

Dotarem (gadoterate meglumine) Injection

Date of Approval: March 20, 2013
Company: Guerbet
Treatment for: Diagnosis and Investigation

Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI).

• FDA Approves Dotarem, a New Magnetic Resonance Imaging Agent
• Dotarem (gadoterate meglumine) FDA Approval History

TOBI Podhaler (tobramycin) Inhalation Powder

Date of Approval: March 22, 2013
Company: Novartis Pharmaceuticals Corporation
Treatment for: Cystic Fibrosis

TOBI Podhaler (tobramycin inhalation powder) is an antibacterial aminoglycoside indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

• FDA Approves TOBI Podhaler to Treat a Type of Bacterial Lung Infection in Cystic Fibrosis Patients
• TOBI Podhaler (tobramycin) FDA Approval History

Tecfidera (dimethyl fumarate) Delayed-Release Capsules - formerly BG-12

Date of Approval: March 27, 2013
Company: Biogen Idec
Treatment for: Multiple Sclerosis

Tecfidera (dimethyl fumarate) is an oral Nrf2 pathway activator for the treatment of relapsing forms of multiple sclerosis.

• FDA Approves Tecfidera - a New Treatment for Multiple Sclerosis
• Tecfidera (dimethyl fumarate) FDA Approval History

Invokana (canagliflozin) Tablets

Date of Approval: March 29, 2013
Company: Janssen Research & Development, LLC
Treatment for: Type 2 Diabetes, Cardiovascular Risk Reduction, Diabetic Kidney Disease

Invokana (canagliflozin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor indicated:

• along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
• to reduce the risk of major cardiovascular events in adults with type 2 diabetes who have known cardiovascular disease
• to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine.

• FDA Approves Invokana to Treat Type 2 Diabetes
• Invokana (canagliflozin) FDA Approval History

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets

Date of Approval: March 28, 2013
Company: Teva Branded Pharmaceutical Products R&D, Inc.
Treatment for: Birth Control

Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) is a 91-day extended regimen oral contraceptive indicated for the prevention of pregnancy.

• FDA Approves Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets for the Prevention of Pregnancy
• Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) FDA Approval History

Karbinal ER (carbinoxamine) Extended-Release Oral Suspension

Date of Approval: March 28, 2013
Company: Tris Pharma, Inc.
Treatment for: Conjunctivitis, Allergic, Allergic Reactions, Allergic Rhinitis, Allergic Urticaria

Karbinal ER (carbinoxamine maleate) extended-release oral suspension is an H1 receptor antagonist indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis.

• FDA Approves Tris Pharma's New Drug Application for Karbinal ER
• Karbinal ER (carbinoxamine) FDA Approval History

Prolensa (bromfenac) Ophthalmic Solution

Date of Approval: April 5, 2013
Company: Bausch + Lomb
Treatment for: Postoperative Ocular Inflammation

Prolensa (bromfenac ophthalmic solution) is a topical nonsteroidal anti-inflammatory indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

• Bausch + Lomb Receives FDA Approval for Prolensa
• Prolensa (bromfenac) FDA Approval History

Diclegis (doxylamine and pyridoxine) Delayed-Release Tablets

Date of Approval: April 8, 2013
Company: Duchesnay Inc.
Treatment for: Nausea and Vomiting of Pregnancy

Diclegis (doxylamine and pyridoxine) is an antihistamine and vitamin B6 analog combination indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

• FDA Approves Diclegis for Pregnant Women Experiencing Nausea and Vomiting
• Diclegis (doxylamine and pyridoxine) FDA Approval History

Sitavig (acyclovir) Buccal Tablets

Date of Approval: April 12, 2013
Company: BioAlliance Pharma SA
Treatment for: Cold Sores

Sitavig (acyclovir) is a mucoadhesive buccal tablet formulation of the antiviral drug acyclovir indicated for the treatment of recurrent orofacial herpes (cold sores).

• BioAlliance Pharma's Sitavig Receives FDA Approval for the Treatment of Herpes Labialis
• Sitavig (acyclovir) FDA Approval History

Simbrinza (brimonidine and brinzolamide) Ophthalmic Suspension

Date of Approval: April 19, 2013
Company: Alcon
Treatment for: Glaucoma

Simbrinza (brimonidine and brinzolamide) is a fixed combination of an alpha 2 adrenergic receptor agonist and a carbonic anhydrase inhibitor indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

• Alcon Announces FDA Approval of Simbrinza Suspension, a New Beta Blocker-Free, Fixed-Combination Therapy for Glaucoma Patients
• Simbrinza (brimonidine and brinzolamide) FDA Approval History

Kcentra (prothrombin complex concentrate, human)

Date of Approval: April 29, 2013
Company: CSL Behring
Treatment for: Reversal of Vitamin K Antagonist (VKA) Anticoagulation

• FDA Approves Kcentra for the Urgent Reversal of Anticoagulation in Adults with Major Bleeding
• Kcentra (prothrombin complex concentrate, human) FDA Approval History

Procysbi (cysteamine bitartrate) Delayed-Release Capsules

Date of Approval: April 30, 2013
Company: Raptor Pharmaceutical Corp.
Treatment for: Nephropathic Cystinosis

Procysbi (cysteamine bitartrate) is a cystine depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.

• FDA Approves Procysbi for Nephropathic Cystinosis
• Procysbi (cysteamine bitartrate) FDA Approval History

Liptruzet (atorvastatin and ezetimibe) Tablets

Date of Approval: May 3, 2013
Company: Merck
Treatment for: High Cholesterol, Familial Heterozygous

Marketing Status: Discontinued

Liptruzet (atorvastatin and ezetimibe) is a statin (HMG-CoA reductase inhibitor) and cholesterol absorption inhibitor combination indicated for the treatment of hyperlipidemia.

• FDA Approves Merck’s Liptruzet (ezetimibe and atorvastatin), a New Product That Can Help Lower LDL Cholesterol
• Liptruzet (atorvastatin and ezetimibe) FDA Approval History

Breo Ellipta (fluticasone and vilanterol) Inhalation Powder

Date of Approval: May 10, 2013
Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Treatment for: COPD, Asthma

Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid/long-acting beta2 agonist (LABA) combination indicated for the treatment of patients with chronic obstructive pulmonary disease (COPD) and asthma.

• FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)
• Breo Ellipta (fluticasone and vilanterol) FDA Approval History

Nymalize (nimodipine) Oral Solution

Date of Approval: May 10, 2013
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Subarachnoid Hemorrhage

Nymalize (nimodipine) is a calcium channel blocker indicated to improve neurological outcome following subarachnoid hemorrhage.

• Arbor Pharmaceuticals Announces FDA Approval of Nymalize
• Nymalize (nimodipine) FDA Approval History

Xofigo (radium Ra 223 dichloride) Injection

Date of Approval: May 15, 2013
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Prostate Cancer

Xofigo (radium 223 dichloride) is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer.

• FDA Approves Xofigo for Advanced Prostate Cancer
• Xofigo (radium Ra 223 dichloride) FDA Approval History

Tafinlar (dabrafenib) Capsules and Tablets for Oral Suspension

Date of Approval: May 29, 2013
Company: Novartis Pharmaceuticals Corporation
Treatment for: Melanoma, Metastatic, Non Small Cell Lung Cancer, Thyroid Cancer, Solid Tumors, Low-Grade Glioma

Tafinlar (dabrafenib) is a kinase inhibitor for the treatment of melanoma, non-small cell lung cancer, thyroid cancer, solid tumors, and low-grade glioma with BRAF V600 mutations.

• FDA Approves Tafinlar (dabrafenib) for Advanced Melanoma
• Tafinlar (dabrafenib) FDA Approval History

Mekinist (trametinib) Tablets and Oral Solution

Date of Approval: May 29, 2013
Company: Novartis Pharmaceuticals Corporation
Treatment for: Melanoma, Metastatic, Non Small Cell Lung Cancer, Thyroid Cancer, Solid Tumors, Low-Grade Glioma

Mekinist (trametinib) is a kinase inhibitor for the treatment of melanoma, non-small cell lung cancer, thyroid cancer, solid tumors, and low-grade glioma with BRAF V600 mutations.

• FDA Approves Mekinist (trametinib) for Advanced Melanoma
• Mekinist (trametinib) FDA Approval History

Bloxiverz (neostigmine methylsulfate) Injection

Date of Approval: May 31, 2013
Company: Flamel Technologies
Treatment for: Reversal of Nondepolarizing Muscle Relaxants

Bloxiverz (neostigmine methylsulfate) is a cholinesterase inhibitor used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.

• Flamel Technologies Announces FDA Approval of Bloxiverz
• Bloxiverz (neostigmine methylsulfate) FDA Approval History

Rixubis (coagulation factor IX (recombinant)) Injection

Date of Approval: June 26, 2013
Company: Baxter International Inc.
Treatment for: Hemophilia B

Rixubis (coagulation factor IX, recombinant) is an antihemophilic factor indicated for the control and prevention of bleeding episodes in adults with hemophilia B.

• FDA Approves Rixubis - First Recombinant Coagulation Factor IX For Use in Preventing Bleeding Episodes
• Rixubis (coagulation factor IX (recombinant)) FDA Approval History

Brisdelle (paroxetine mesylate) Capsules

Date of Approval: June 28, 2013
Company: Noven Pharmaceuticals, Inc.
Treatment for: Hot Flashes Associated with Menopause

Brisdelle (paroxetine mesylate) is a low-dose selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.

• FDA Approves Brisdelle - First Non-Hormonal Treatment for Hot Flashes Associated with Menopause
• Brisdelle (paroxetine mesylate) FDA Approval History

Zubsolv (buprenorphine and naloxone) Sublingual Tablets

Date of Approval: July 3, 2013
Company: Orexo AB
Treatment for: Opioid Use Disorder

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

• FDA Approves Zubsolv for the Maintenance Treatment of Opioid Dependence
• Zubsolv (buprenorphine and naloxone) FDA Approval History

Khedezla (desvenlafaxine) Extended-Release Tablets

Date of Approval: July 10, 2013
Company: Osmotica Pharmaceutical Corp.
Treatment for: Depression

Khedezla (desvenlafaxine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.

• FDA Approves Khedezla for Major Depressive Disorder
• Khedezla (desvenlafaxine) FDA Approval History

Gilotrif (afatinib) Tablets

Date of Approval: July 12, 2013
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: Non Small Cell Lung Cancer

Gilotrif (afatinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).

• FDA Approves Gilotrif for Late Stage Non-Small Cell Lung Cancer
• Gilotrif (afatinib) FDA Approval History

Simponi Aria (golimumab) Injection

Date of Approval: July 18, 2013
Company: Janssen Biotech, Inc.

Simponi Aria (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of:

• Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate
• Active Psoriatic Arthritis (PsA) in patients 2 years of age and older
• Adult patients with active Ankylosing Spondylitis (AS)
• Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older

• Simponi Aria (golimumab) for Infusion Receives FDA Approval for Treatment of Moderately to Severely Active Rheumatoid Arthritis
• Simponi Aria (golimumab) FDA Approval History

Astagraf XL (tacrolimus) Extended-Release Capsules

Date of Approval: July 19, 2013
Company: Astellas Pharma US, Inc.
Treatment for: Organ Transplant, Rejection Prophylaxis

Astagraf XL (tacrolimus) is a calcineurin-inhibitor immunosuppressant for the prophylaxis of organ rejection in patients receiving a kidney transplant.

• Astellas Announces FDA Approval of Astagraf XL (tacrolimus extended-release capsules) for the Prophylaxis of Organ Rejection
• Astagraf XL (tacrolimus) FDA Approval History

Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) Tablets

Date of Approval: July 24, 2013
Company: Warner Chilcott plc
Treatment for: Birth Control

Marketing Status: Discontinued

Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) is an estrogen/progestin combined oral contraceptive indicated for use by women to prevent pregnancy.

• Warner Chilcott Announces FDA Approval of Lo Minastrin Fe
• Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) FDA Approval History

Injectafer (ferric carboxymaltose) Injection

Date of Approval: July 25, 2013
Company: Daiichi Sankyo, Inc.
Treatment for: Iron Deficiency Anemia

Injectafer (ferric carboxymaltose) is an iron replacement product for the treatment of iron deficiency anemia.

• FDA Approves Injectafer for Iron Deficiency Anemia
• Injectafer (ferric carboxymaltose) FDA Approval History

Fetzima (levomilnacipran) Extended-Release Capsules

Date of Approval: July 25, 2013
Company: AbbVie Inc.
Treatment for: Depression

Fetzima (levomilnacipran) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.

• Forest Laboratories and Pierre Fabre Laboratories Announce FDA Approval of Fetzima for the Treatment of Major Depressive Disorder in Adults
• Fetzima (levomilnacipran) FDA Approval History

Tivicay (dolutegravir) Tablets

Date of Approval: August 12, 2013
Company: ViiV Healthcare
Treatment for: HIV Infection

Tivicay (dolutegravir) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1.

• FDA Approves Tivicay (dolutegravir) to Treat HIV Infection
• Tivicay (dolutegravir) FDA Approval History

Epaned (enalapril maleate) Oral Solution

Date of Approval: August 13, 2013
Company: Azurity Pharmaceuticals, Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction

Epaned (enalapril maleate) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month, symptomatic heart failure, and asymptomatic left ventricular dysfunction.

• FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults
• Epaned (enalapril maleate) FDA Approval History

FluLaval Quadrivalent (influenza virus vaccine, inactivated)

Date of Approval: August 16, 2013
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis

FluLaval Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease in people aged 6 months and older.

• FDA Approves FluLaval Quadrivalent
• FluLaval Quadrivalent (influenza virus vaccine, inactivated) FDA Approval History

Trokendi XR (topiramate)

Date of Approval: August 16, 2013
Company: Supernus Pharmaceuticals, Inc.
Treatment for: Epilepsy

Trokendi XR (topiramate) is an antiepileptic drug indicated for the treatment of epilepsy.

• Supernus Announces Final FDA Approval and Upcoming Launch of Trokendi XR
• Trokendi XR (topiramate) FDA Approval History

Valchlor (mechlorethamine) Topical Gel

Date of Approval: August 23, 2013
Company: Ceptaris Therapeutics, Inc.
Treatment for: Mycosis Fungoides

Valchlor (mechlorethamine) gel an alkylating agent indicated for the topical treatment of Stage IA and IB mycosis fungoides‐type cutaneous T‐cell lymphoma.

• Ceptaris Receives FDA Approval for Valchlor (mechlorethamine) Gel for the Treatment of Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma
• Valchlor (mechlorethamine) FDA Approval History

Mirvaso (brimonidine) Topical Gel

Date of Approval: August 23, 2013
Company: Galderma Laboratories, L.P.
Treatment for: Rosacea

Mirvaso (brimonidine) topical gel is an alpha adrenergic agonist indicated for the topical treatment of facial erythema of rosacea.

• Galderma Receives FDA Approval of Mirvaso for the Topical Treatment of Facial Erythema of Rosacea
• Mirvaso (brimonidine) FDA Approval History

Trintellix (vortioxetine) Tablets - formerly Brintellix

Date of Approval: September 30, 2013
Company: Takeda Pharmaceutical Company Limited and H. Lundbeck A/S
Treatment for: Depression

Trintellix (vortioxetine) is a multimodal antidepressant for the treatment of major depressive disorder (MDD).

• FDA Approves Brintellix to Treat Major Depressive Disorder
• Trintellix (vortioxetine) FDA Approval History

Duavee (bazedoxifene and conjugated estrogens) Tablets

Date of Approval: October 3, 2013
Company: Pfizer Inc.
Treatment for: Postmenopausal Symptoms, Prevention of Osteoporosis

Duavee (bazedoxifene and conjugated estrogens) is an estrogen agonist/antagonist and conjugated estrogens combination indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, and prevention of postmenopausal osteoporosis in women with an intact uterus.

• FDA Approves Duavee to Treat Hot Flashes and Prevent Osteoporosis
• Duavee (bazedoxifene and conjugated estrogens) FDA Approval History

Clinolipid (lipid injectable emulsion) for Intravenous Use

Date of Approval: October 3, 2013
Company: Baxter Healthcare Corporation
Treatment for: Parenteral Nutrition

Clinolipid (lipid injectable emulsion) is an intravenous fat supplement used for parenteral nutrition.

• FDA Approves Clinolipid for Intravenous Nutrition
• Clinolipid (lipid injectable emulsion) FDA Approval History

Adempas (riociguat) Tablets

Date of Approval: October 8, 2013
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Pulmonary Arterial Hypertension

Adempas (riociguat) is an oral soluble guanylate cyclase (sGC) stimulator for the treatment of pulmonary hypertension.

• FDA Approves Adempas to Treat Pulmonary Hypertension
• Adempas (riociguat) FDA Approval History

Otrexup (methotrexate) Subcutaneous Injection

Date of Approval: October 11, 2013
Company: Antares Pharma, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriasis

Otrexup (methotrexate) is a folate analog metabolic inhibitor self-administered once weekly for use in the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriasis.

• Otrexup (Methotrexate) Injection Approved By FDA
• Otrexup (methotrexate) FDA Approval History

Novoeight (turoctocog alfa) for Intravenous Injection

Date of Approval: October 15, 2013
Company: Novo Nordisk
Treatment for: Hemophilia A

Novoeight (turoctocog alfa) is an antihemophilic factor (recombinant) indicated for use in adults and children with hemophilia A.

• NovoEight (turoctocog alfa) Receives Approval from the FDA
• Novoeight (turoctocog alfa) FDA Approval History

Zorvolex (diclofenac) Capsules

Date of Approval: October 18, 2013
Company: Iroko Pharmaceuticals, LLC
Treatment for: Pain, Osteoarthritis

Zorvolex (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain, and for the management of osteoarthritis pain.

• Iroko Pharmaceuticals Receives FDA Approval for Zorvolex
• Zorvolex (diclofenac) FDA Approval History

Opsumit (macitentan) Tablets

Date of Approval: October 18, 2013
Company: Actelion Pharmaceuticals Ltd.
Treatment for: Pulmonary Arterial Hypertension

Opsumit (macitentan) is a dual endothelin receptor antagonist for the treatment of patients with pulmonary arterial hypertension.

• FDA Approves Opsumit to Treat Pulmonary Arterial Hypertension
• Opsumit (macitentan) FDA Approval History

Zohydro ER (hydrocodone) Extended-Release Capsules

Date of Approval: October 25, 2013
Company: Zogenix, Inc.
Treatment for: Pain

Zohydro ER (hydrocodone) is a single-entity (without acetaminophen) extended-release opioid analgesic for around-the-clock management of moderate to severe chronic pain.

• FDA Approves Zohydro ER, an Extended-Release, Single-Entity Hydrocodone Product
• Zohydro ER (hydrocodone) FDA Approval History

Vizamyl (flutemetamol F 18) Injection

Date of Approval: October 25, 2013
Company: GE Healthcare
Treatment for: Diagnosis and Investigation

Vizamyl (flutemetamol F 18) is a PET amyloid imaging agent for the evaluation of Alzheimer's disease and other cognitive disorders.

• FDA Approves Vizamyl Brain Imaging Drug to Help Evaluate Patients for Alzheimer’s Disease, Dementia
• Vizamyl (flutemetamol F 18) FDA Approval History

Gazyva (obinutuzumab) Injection

Date of Approval: November 1, 2013
Company: Genentech
Treatment for: Chronic Lymphocytic Leukemia, Follicular Lymphoma

Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated for the combination treatment of patients with chronic lymphocytic leukemia and follicular lymphoma.

• FDA Approves Gazyva for Chronic Lymphocytic Leukemia
• Gazyva (obinutuzumab) FDA Approval History

Aptiom (eslicarbazepine acetate) Tablets - formerly Stedesa

Date of Approval: November 8, 2013
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Epilepsy, Seizures

Aptiom (eslicarbazepine acetate) is a voltage-gated sodium channel blocker for the treatment of partial-onset seizures in patients with epilepsy.

• FDA Approves Aptiom to Treat Seizures in Adults
• Aptiom (eslicarbazepine acetate) FDA Approval History

Imbruvica (ibrutinib) Capsules, Tablets and Oral Suspension

Date of Approval: November 13, 2013
Company: AbbVie Inc.
Treatment for: Chronic Lymphocytic Leukemia, Waldenström Macroglobulinemia, Graft Versus Host Disease

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD).

• FDA Approves Imbruvica (ibrutinib) for Mantle Cell Lymphoma
• Imbruvica (ibrutinib) FDA Approval History

Luzu (luliconazole) Topical Cream

Date of Approval: November 14, 2013
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Tinea Corporis, Tinea Pedis, Tinea Cruris

Luzu (luliconazole) Cream is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis.

• Valeant Pharmaceuticals Announces U.S. Approval Of Luzu Cream, 1%
• Luzu (luliconazole) FDA Approval History

Olysio (simeprevir) Capsules

Date of Approval: November 22, 2013
Company: Janssen Research & Development, LLC
Treatment for: Hepatitis C

Olysio (simeprevir) is a protease inhibitor for the treatment of chronic hepatitis C virus infection.

• FDA Approves Olysio (simeprevir) for Hepatitis C Virus
• Olysio (simeprevir) FDA Approval History

Varithena (polidocanol) Injectable Foam

Date of Approval: November 25, 2013
Company: BTG plc
Treatment for: Varicose Veins

Varithena (polidocanol) injectable foam is a sclerosing agent indicated for the treatment of varicose veins.

• FDA Approves Varithena (Polidocanol Injectable Foam) for the Treatment of Patients with Varicose Veins
• Varithena (polidocanol) FDA Approval History

Velphoro (sucroferric oxyhydroxide) Chewable Tablets

Date of Approval: November 27, 2013
Company: Vifor Fresenius Medical Care Renal Pharma
Treatment for: Hyperphosphatemia of Renal Failure

Velphoro (sucroferric oxyhydroxide) is a chewable, iron-based phosphate binder for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis.

• Velphoro Receives US FDA Approval for the Treatment of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis
• Velphoro (sucroferric oxyhydroxide) FDA Approval History

Sovaldi (sofosbuvir) Tablets and Oral Pellets

Date of Approval: December 6, 2013
Company: Gilead Sciences
Treatment for: Hepatitis C

Sovaldi (sofosbuvir) is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of:

• adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen.
• pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.

• FDA Approves Sovaldi for Chronic Hepatitis C
• Sovaldi (sofosbuvir) FDA Approval History

Anoro Ellipta (umeclidinium bromide and vilanterol)

Date of Approval: December 18, 2013
Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Treatment for: COPD

Anoro Ellipta (umeclidinium bromide and vilanterol) is a long-acting muscarinic antagonist (LAMA) and long-acting beta2 agonist (LABA) combination for the treatment of COPD.

• FDA Approves Anoro Ellipta to Treat Chronic Obstructive Pulmonary Disease
• Anoro Ellipta (umeclidinium bromide and vilanterol) FDA Approval History

Tretten (coagulation factor XIII A-subunit (recombinant))

Date of Approval: December 23, 2013
Company: Novo Nordisk A/S
Treatment for: Factor XIII A-Subunit Deficiency

Tretten (coagulation factor XIII A-subunit (recombinant)) is a recombinant analogue of the human Factor XIII A-subunit for the prevention of bleeding in patients who have the rare clotting disorder congenital Factor XIII A-subunit deficiency.

• FDA Approves Tretten to Treat Rare Genetic Clotting Disorder
• Tretten (coagulation factor XIII A-subunit (recombinant)) FDA Approval History

Orenitram (treprostinil) Extended-Release Tablets

Date of Approval: December 20, 2013
Company: United Therapeutics Corporation
Treatment for: Pulmonary Arterial Hypertension

Orenitram (treprostinil extended-release) is an oral prostacyclin for the treatment of pulmonary arterial hypertension.

• FDA Approves Orenitram (treprostinil) Extended-Release Tablets for the Treatment of Pulmonary Arterial Hypertension
• Orenitram (treprostinil) FDA Approval History

Epaned (enalapril maleate) Oral Solution

Date of Approval: August 13, 2013
Company: Azurity Pharmaceuticals, Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction

Epaned (enalapril maleate) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month, symptomatic heart failure, and asymptomatic left ventricular dysfunction.

• FDA Approves Two New Indications for Epaned, the First and Only Enalapril Powder for Oral Solution
• Epaned (enalapril maleate) FDA Approval History

Zubsolv (buprenorphine and naloxone) Sublingual Tablets

Date of Approval: July 3, 2013
Company: Orexo AB
Treatment for: Opioid Use Disorder

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

• FDA Approves Unique Low Dosage of Zubsolv
• Zubsolv (buprenorphine and naloxone) FDA Approval History

Epaned (enalapril maleate) Oral Solution

Date of Approval: August 13, 2013
Company: Azurity Pharmaceuticals, Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction

Epaned (enalapril maleate) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month, symptomatic heart failure, and asymptomatic left ventricular dysfunction.

• Epaned (enalapril maleate) Oral Solution is Now Available
• Epaned (enalapril maleate) FDA Approval History