New Drug Approvals Archive for 2011

Abstral (fentanyl) Sublingual Tablets

Date of Approval: January 7, 2011
Company: Orexo AB
Treatment for: Pain

Marketing Status: Discontinued

Abstral (fentanyl) is a sublingual opioid analgesic indicated for the management of breakthrough pain in cancer patients.

• FDA Approval for Abstral (Fentanyl) Sublingual Tablets
• Abstral (fentanyl) FDA Approval History

DaTscan (ioflupane I 123) Injection

Date of Approval: January 14, 2011
Company: GE Healthcare
Treatment for: Diagnosis and Investigation

DaTscan (ioflupane I 123 injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).

• FDA Approves DaTscan (Ioflupane I 123 Injection) for Visualization of Dopamine Transporters in Patients with Suspected Parkinsonian Syndromes
• DaTscan (ioflupane I 123) FDA Approval History

Natroba (spinosad) Topical Suspension

Date of Approval: January 18, 2011
Company: ParaPRO LLC
Treatment for: Lice

Natroba (spinosad) is a pediculicide indicated for the topical treatment of head lice infestations.

• FDA Approves Natroba Head Lice Treatment for Children and Adults
• Natroba (spinosad) FDA Approval History

Viibryd (vilazodone) Tablets

Date of Approval: January 21, 2011
Company: AbbVie Inc.
Treatment for: Depression

Viibryd (vilazodone) is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist indicated for the treatment of major depressive disorder (MDD).

• FDA Approves Viibryd to Treat Major Depressive Disorder
• Viibryd (vilazodone) FDA Approval History

Gralise (gabapentin) Extended Release Tablets - formerly DM-1796

Date of Approval: January 28, 2011
Company: Depomed, Inc.
Treatment for: Postherpetic Neuralgia

Gralise (gabapentin) is an extended release, tablet formulation of the approved antiepileptic agent gabapentin, indicated for the once-daily treatment of post-herpetic neuralgia (PHN).

• Depomed Announces US Food and Drug Administration Approval of Gralise (gabapentin) Once-Daily Tablets for Treatment of Post-Herpetic Neuralgia
• Gralise (gabapentin) FDA Approval History

Makena (hydroxyprogesterone caproate) Injection - formerly Gestiva

Date of Approval: February 3, 2011
Company: AMAG Pharmaceuticals, Inc.
Treatment for: Premature Labor

Makena (hydroxyprogesterone caproate) was a long acting form of natural progesterone approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth.

• FDA Approves Makena to Reduce Risk of Preterm Birth in At-Risk Pregnant Women
• Makena (hydroxyprogesterone caproate) FDA Approval History

Corifact (factor XIII concentrate (human))

Date of Approval: February 17, 2011
Company: CSL Behring LLC
Treatment for: Factor XIII Deficiency

Corifact (factor XIII concentrate (human)) is a is a fibrin-stabilizing factor concentrate indicated to prevent bleeding in people with congenital Factor XIII deficiency.

• FDA Approves Corifact to Prevent Bleeding in People With Rare Genetic Defect
• Corifact (factor XIII concentrate (human)) FDA Approval History

Edarbi (azilsartan medoxomil) Tablets

Date of Approval: February 25, 2011
Company: Azurity Pharmaceuticals, Inc.
Treatment for: High Blood Pressure

Edarbi (azilsartan medoxomil) is an angiotensin II receptor blocker (ARB) for the treatment of hypertension.

• FDA Approves Edarbi to Treat High Blood Pressure
• Edarbi (azilsartan medoxomil) FDA Approval History

Daliresp (roflumilast) Tablets - formerly Daxas

Date of Approval: February 28, 2011
Company: Allergan, Inc.
Treatment for: COPD

Daliresp (roflumilast) is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

• FDA Approves Daliresp to Treat Chronic Obstructive Pulmonary Disease
• Daliresp (roflumilast) FDA Approval History

Benlysta (belimumab) Injection

Date of Approval: March 10, 2011
Company: GlaxoSmithKline
Treatment for: Lupus Erythematosus, Lupus Nephritis

Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor for the treatment of active systemic lupus erythematosus (SLE) and active lupus nephritis.

• FDA Approves Benlysta to Treat Lupus
• Benlysta (belimumab) FDA Approval History

Gadavist (gadobutrol) Injection

Date of Approval: March 14, 2011
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Diagnosis and Investigation

Gadavist (gadobutrol) is a gadolinium-based contrast agent indicated for use in diagnostic magnetic resonance imaging (MRI).

• U.S. FDA Approves Bayer's Gadavist (gadobutrol) Injection for MRI of the Central Nervous System
• Gadavist (gadobutrol) FDA Approval History

(adenovirus type 4 and type 7 vaccine)

Date of Approval: March 16, 2011
Company: Barr Laboratories, Inc.
Treatment for: Infection Prophylaxis

Adenovirus type 4 and type 7 vaccine is an oral vaccine indicated for the prevention of febrile acute respiratory disease caused by adenovirus type 4 and type 7 in military populations.

• FDA Approves the New Adenovirus Vaccine
• adenovirus type 4 and type 7 vaccine FDA Approval History

Yervoy (ipilimumab) Injection

Date of Approval: March 25, 2011
Company: Bristol-Myers Squibb
Treatment for: Melanoma, Metastatic, Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non Small Cell Lung Cancer, Malignant Pleural Mesothelioma, Esophageal Carcinoma

Yervoy (ipilimumab) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody used for the treatment of melanoma, and in combination with Opdivo (nivolumab) for the treatment of renal cell carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal cancer.

• FDA Approves Yervoy for Late-Stage Melanoma
• Yervoy (ipilimumab) FDA Approval History

Caprelsa (vandetanib) Tablets

Date of Approval: April 6, 2011
Company: AstraZeneca
Treatment for: Thyroid Cancer

Caprelsa (vandetanib) is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable (non-operable) locally advanced or metastatic disease.

• FDA Approves Orphan Drug Vandetanib for Advanced Medullary Thyroid Cancer
• Caprelsa (vandetanib) FDA Approval History

Horizant (gabapentin enacarbil) Extended Release Tablets - formerly Solzira

Date of Approval: April 6, 2011
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Restless Legs Syndrome, Postherpetic Neuralgia

Horizant (gabapentin enacarbil) is a gabapentin prodrug indicated for the once-daily treatment of restless legs syndrome and postherpetic neuralgia.

• GlaxoSmithKline and XenoPort Receive FDA Approval for Horizant
• Horizant (gabapentin enacarbil) FDA Approval History

Sylatron (peginterferon alfa-2b)

Date of Approval: March 29, 2011
Company: Merck
Treatment for: Melanoma

Sylatron (peginterferon alfa-2b) is an alpha interferon indicated for the adjuvant treatment of melanoma.

• FDA Approves Merck's Sylatron (peginterferon alfa-2b) for Injection, a New Adjuvant Treatment for Melanoma with Microscopic or Gross Nodal Involvement
• Sylatron (peginterferon alfa-2b) FDA Approval History

Duexis (famotidine and ibuprofen) Tablets

Date of Approval: April 23, 2011
Company: Horizon Pharma, Inc.
Treatment for: Osteoarthritis, Rheumatoid Arthritis, NSAID-Induced Ulcer Prophylaxis

Duexis (ibuprofen and famotidine) is an NSAID and histamine H2-receptor antagonist combination indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper GI ulcers.

• Horizon Pharma Announces FDA Approval of Duexis (Ibuprofen/Famotidine)
• Duexis (famotidine and ibuprofen) FDA Approval History

Zytiga (abiraterone) Tablets

Date of Approval: April 28, 2011
Company: Centocor Ortho Biotech Inc.
Treatment for: Prostate Cancer

Zytiga (abiraterone acetate) is a CYP17 inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.

• FDA Approves Zytiga for Late-Stage Prostate Cancer
• Zytiga (abiraterone) FDA Approval History

Tradjenta (linagliptin) Tablets

Date of Approval: May 2, 2011
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: Type 2 Diabetes

Tradjenta (linagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• FDA Approves Tradjenta for Type 2 Diabetes
• Tradjenta (linagliptin) FDA Approval History

Docefrez (docetaxel) for Injection

Date of Approval: May 3, 2011
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Breast Cancer, Non Small Cell Lung Cancer, Prostate Cancer

Marketing Status: Discontinued

Docefrez (docetaxel) is a microtubule inhibitor indicated for the treatment of metastatic breast cancer, metastatic non-small cell lung cancer and hormone refractory metastatic prostate cancer.

• Sun Pharma Announces US FDA Approval for Docefrez (docetaxel) for Injection
• Docefrez (docetaxel) FDA Approval History

Victrelis (boceprevir)

Date of Approval: May 13, 2011
Company: Merck
Treatment for: Hepatitis C

Marketing Status: Discontinued

Victrelis (boceprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C.

• FDA Approves Merck's Victrelis (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
• Victrelis (boceprevir) FDA Approval History

Edurant (rilpivirine) Tablets and Tablets for Oral Suspension

Date of Approval: May 20, 2011
Company: Janssen Products, LP
Treatment for: HIV Infection

Edurant (rilpivirine) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of HIV-1 infection.

• FDA Approves New HIV Treatment Edurant (rilpivirine)
• Edurant (rilpivirine) FDA Approval History

Incivek (telaprevir) Tablets

Date of Approval: May 23, 2011
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Hepatitis C

Marketing Status: Discontinued

Incivek (telaprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of chronic hepatitis C (CHC).

• FDA Approves Incivek (telaprevir) for People with Hepatitis C
• Incivek (telaprevir) FDA Approval History

Dificid (fidaxomicin)

Date of Approval: May 27, 2011
Company: Merck
Treatment for: Clostridioides difficile Infection

Dificid (fidaxomicin) is a macrolide antibacterial drug indicated for the treatment of Clostridioides difficile-associated diarrhea.

• FDA Approves Dificid for Clostridium difficile Infection
• Dificid (fidaxomicin) FDA Approval History

Potiga (ezogabine) Tablets

Date of Approval: June 10, 2011
Company: GlaxoSmithKline and Valeant Pharmaceuticals International
Treatment for: Seizures

Marketing Status: Discontinued

Potiga (ezogabine) is a potassium channel opener indicated for the adjunctive treatment of adults with partial-onset seizures.

• Valeant and GlaxoSmithKline Announce U.S. FDA Approval of Potiga (ezogabine)
• Potiga (ezogabine) FDA Approval History

Nulojix (belatacept) Injection

Date of Approval: June 15, 2011
Company: Bristol-Myers Squibb Company
Treatment for: Organ Transplant, Rejection Prophylaxis

Nulojix (belatacept) is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant.

• FDA Approves Nulojix for Kidney Transplant Patients
• Nulojix (belatacept) FDA Approval History

Oxecta (oxycodone) Tablets - formerly Acurox

Date of Approval: June 17, 2011
Company: Pfizer Inc. and Acura Pharmaceuticals Inc.
Treatment for: Pain

Marketing Status: Discontinued

Oxecta (oxycodone hydrochloride) is an abuse-deterrent opioid analgesic formulation for the relief of moderate to severe pain.

• Pfizer and Acura Announce FDA Approval of Oxecta (Oxycodone HCl, USP) CII
• Oxecta (oxycodone) FDA Approval History

Rectiv (nitroglycerin) Ointment

Date of Approval: June 21, 2011
Company: AbbVie Inc.
Treatment for: Anal Fissure and Fistula

Rectiv (nitroglycerin) is a topical ointment for the treatment of moderate to severe pain associated with chronic anal fissures.

• ProStrakan Receives FDA Approval for Rectiv for the Treatment of Moderate to Severe Pain Associated With Chronic Anal Fissures
• Rectiv (nitroglycerin) FDA Approval History

LaViv (azficel-T)

Date of Approval: June 21, 2011
Company: Fibrocell Science, Inc.
Treatment for: Wrinkles

Azficel-T is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

• Fibrocell Science, Inc. Announces FDA Approval for laViv (azficel-T)
• LaViv (azficel-T) FDA Approval History

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) Oral Solution

Date of Approval: June 8, 2011
Company: Cypress Pharmaceutical, Inc.
Treatment for: Cough and Nasal Congestion

Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) Oral Solution is a combination product containing an antitussive, an antihistamine, and a nasal decongestant indicated for the relief of cough and nasal congestion associated with the common cold and upper respiratory allergies.

• FDA Approves Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution
• Zutripro (chlorpheniramine, hydrocodone and pseudoephedrine) FDA Approval History

Rezira (hydrocodone and pseudoephedrine) Oral Solution

Date of Approval: June 8, 2011
Company: Cypress Pharmaceutical, Inc.
Treatment for: Cough and Nasal Congestion

Rezira (hydrocodone and pseudoephedrine) Oral Solution is a combination product containing an antitussive and nasal decongestant indicated for the relief of cough and nasal congestion associated with the common cold.

• FDA Approves Rezira (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution
• Rezira (hydrocodone and pseudoephedrine) FDA Approval History

Lazanda (fentanyl) Nasal Spray - formerly NasalFent

Date of Approval: June 30, 2011
Company: Archimedes Pharma
Treatment for: Pain

Lazanda (fentanyl) is an opioid analgesic nasal spray for the management of breakthrough pain in cancer patients.

• FDA Approves Lazanda - First Fentanyl Nasal Spray - for the Management of Breakthrough Pain in Cancer Patients
• Lazanda (fentanyl) FDA Approval History

Xarelto (rivaroxaban) Tablets and Oral Suspension

Date of Approval: July 1, 2011
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Prevention of Thromboembolism in Atrial Fibrillation, Coronary Artery Disease, Peripheral Arterial Disease, Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

Xarelto (rivaroxaban) is a factor Xa inhibitor used for the treatment and prevention of blood clots that are related to certain conditions involving the heart and blood vessels.

• FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
• Xarelto (rivaroxaban) FDA Approval History

Arcapta (indacaterol) Neohaler - formerly QAB149

Date of Approval: July 1, 2011
Company: Novartis Pharmaceuticals Corp.
Treatment for: COPD

Arcapta (indacaterol inhalation powder) is a long-acting beta2-agonist (LABA) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

• FDA Approves Arcapta Neohaler to treat Chronic Obstructive Pulmonary Disease
• Arcapta (indacaterol) FDA Approval History

Brilinta (ticagrelor) Tablets

Date of Approval: July 20, 2011
Company: AstraZeneca
Treatment for: Acute Coronary Syndrome, Coronary Artery Disease, Cardiovascular Risk Reduction, Ischemic Stroke, Prophylaxis

Brilinta (ticagrelor) is a P2Y₁₂ platelet inhibitor indicated:

• to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.
  Brilinta also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.
• to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of Brilinta was established in a population with type 2 diabetes mellitus (T2DM).
• to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA).

• FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes
• Brilinta (ticagrelor) FDA Approval History

Anascorp (antivenom (centruroides scorpion)) Injection

Date of Approval: August 3, 2011
Treatment for: Scorpion Stings

Anascorp (Centruroides (Scorpion) Immune F(ab’)2 (Equine)) is an antivenom indicated for treatment of clinical signs of scorpion envenomation.

• FDA Approves Anascorp - First Specific Treatment for Scorpion Stings
• Anascorp (antivenom (centruroides scorpion)) FDA Approval History

Complera (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets

Date of Approval: August 10, 2011
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a combination of three antiretroviral medications indicated for the once daily treatment of HIV-1 infection in treatment-naïve adults.

• U.S. Food and Drug Administration Approves Gilead Sciences' Complera, a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults
• Complera (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) FDA Approval History

Propel (mometasone furoate) Implant

Date of Approval: August 15, 2011
Company: Intersect ENT, Inc.
Treatment for: Sinusitis

Propel (mometasone furoate) is a corticosteroid implant offering localized, controlled drug delivery for chronic sinusitis patients.

• Intersect ENT Announces U.S. Food and Drug Administration Approval for Propel - First Drug Releasing Implant for Chronic Sinusitis Patients
• Propel (mometasone furoate) FDA Approval History

Zelboraf (vemurafenib) Tablets

Date of Approval: August 17, 2011
Company: Genentech, Inc.
Treatment for: Melanoma, Metastatic

Zelboraf (vemurafenib) is a kinase inhibitor indicated for the treatment of patients with metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test, and for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.

• FDA Approves Zelboraf and Companion Diagnostic Test for Late-Stage Skin Cancer
• Zelboraf (vemurafenib) FDA Approval History

Adcetris (brentuximab vedotin) Injection

Date of Approval: August 19, 2011
Company: Seagen Inc.
Treatment for: Lymphoma, Hodgkin's Lymphoma, Mycosis Fungoides, Diffuse Large B-Cell Lymphoma

Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) used for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma, mycosis fungoides, and large B-cell lymphoma.

• FDA Approves Adcetris to Treat Two Types of Lymphoma
• Adcetris (brentuximab vedotin) FDA Approval History

Firazyr (icatibant) Injection

Date of Approval: August 25, 2011
Company: Shire plc
Treatment for: Angioedema

Firazyr (icatibant) is a selective B2 bradykinin receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema.

• FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE)
• Firazyr (icatibant) FDA Approval History

Xalkori (crizotinib) Capsules and Oral Pellets

Date of Approval: August 26, 2011
Company: Pfizer Inc.
Treatment for: Non Small Cell Lung Cancer, Anaplastic Large Cell Lymphoma - ALK-Positive, Inflammatory Myofibroblastic Tumor

Xalkori (crizotinib) is an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK or ROS1-positive non-small cell lung cancer, ALK-positive anaplastic large cell lymphoma, and ALK-positive inflammatory myofibroblastic tumors.

• FDA Approves Xalkori with Companion Diagnostic for a Type of Late-Stage Lung Cancer
• Xalkori (crizotinib) FDA Approval History

Juvisync (simvastatin and sitagliptin) Tablets

Date of Approval: October 7, 2011
Company: Merck & Co., Inc.
Treatment for: Type 2 Diabetes, High Cholesterol, Familial Homozygous, High Cholesterol, Familial Heterozygous, Hypertriglyceridemia

Marketing Status: Discontinued

Juvisync (simvastatin and sitagliptin) is an HMG-CoA reductase inhibitor (statin) and dipeptidyl peptidase-4 (DPP-4) inhibitor fixed dose combination for the treatment of high cholesterol and type 2 diabetes.

• FDA Approves Combination Therapy Juvisync
• Juvisync (simvastatin and sitagliptin) FDA Approval History

Ferriprox (deferiprone) Tablets and Oral Solution

Date of Approval: October 14, 2011
Company: ApoPharma Inc.
Treatment for: Thalassemia, Iron Overload, Sickle Cell Anemia

Ferriprox (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload in:

• thalassemia syndromes
• sickle cell disease or other anemias.

Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age and Ferriprox Oral Solution is indicated in patients ≥3 years of age.

• FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body
• Ferriprox (deferiprone) FDA Approval History

Onfi (clobazam) Tablets

Date of Approval: October 21, 2011
Company: Lundbeck Inc.
Treatment for: Lennox-Gastaut Syndrome

Onfi (clobazam) is a benzodiazepine antiepileptic drug for the treatment of patients with Lennox-Gastaut syndrome (LGS).

• FDA Approves Onfi for Seizures Associated with Lennox-Gastaut Syndrome
• Onfi (clobazam) FDA Approval History

Exparel (bupivacaine liposome) Injectable Suspension

Date of Approval: October 28, 2011
Company: Pacira Pharmaceuticals, Inc.
Treatment for: Postoperative Pain

Exparel (bupivacaine liposome) is a long-acting amide local anesthetic used for postsurgical analgesia.

• Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of Exparel For Postsurgical Pain Management
• Exparel (bupivacaine liposome) FDA Approval History

Forfivo XL (bupropion hydrochloride) Extended Release Tablets

Date of Approval: November 10, 2011
Company: IntelGenx Corp.
Treatment for: Depression

Forfivo XL (bupropion) is a high-strength formulation of the aminoketone antidepressant bupropion (contained in Wellbutrin) indicated for the treatment of major depressive disorder.

• IntelGenx Announces FDA Approval of its High Dose Anti-Depressant Forfivo XL
• Forfivo XL (bupropion hydrochloride) FDA Approval History

Belotero Balance (dermal filler)

Date of Approval: November 16, 2011
Company: Merz Pharmaceuticals, LLC
Treatment for: Facial Wrinkles

Belotero Balance (dermal filler) is a hyaluronic acid-based cohesive gel dermal filler for the correction of moderate to severe facial wrinkles and folds.

• Merz Aesthetics Announces FDA Approval of Belotero Balance Dermal Filler for the Correction of Moderate-to-Severe Facial Wrinkles and Folds
• Belotero Balance (dermal filler) FDA Approval History

Jakafi (ruxolitinib) Tablets

Date of Approval: November 16, 2011
Company: Incyte Corporation
Treatment for: Myelofibrosis, Polycythemia Vera, Graft Versus Host Disease

Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor used for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.

• FDA Approves Jakafi to Treat Myelofibrosis
• Jakafi (ruxolitinib) FDA Approval History

Erwinaze (asparaginase Erwinia chrysanthemi) Injection

Date of Approval: November 18, 2011
Company: Jazz Pharmaceuticals
Treatment for: Acute Lymphoblastic Leukemia

Erwinaze (asparaginase Erwinia chrysanthemi) is an antineoplastic agent used to treat patients with acute lymphoblastic leukemia (ALL) who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs.

• FDA Approves Erwinaze to Treat Acute Lymphoblastic Leukemia
• Erwinaze (asparaginase Erwinia chrysanthemi) FDA Approval History

Eylea (aflibercept) Injection

Date of Approval: November 18, 2011
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Macular Degeneration, Macular Edema, Diabetic Retinopathy, Diabetic Macular Edema, Retinopathy of Prematurity

Eylea (aflibercept) is a VEGF inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and retinopathy of prematurity.

• FDA Approves Eylea for Wet Age-Related Macular Degeneration
• Eylea (aflibercept) FDA Approval History

Intermezzo (zolpidem tartrate) Sublingual Tablets

Date of Approval: November 23, 2011
Company: Transcept Pharmaceuticals, Inc.
Treatment for: Insomnia

Marketing Status: Discontinued

Intermezzo is a low dose, fast acting, sublingual formulation of the hypnotic agent zolpidem, indicated for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

• FDA Approves Intermezzo for Middle-of-the-Night Waking Followed by Difficulty Returning to Sleep
• Intermezzo (zolpidem tartrate) FDA Approval History

Anturol (oxybutynin) Gel

Date of Approval: December 7, 2011
Company: Antares Pharma, Inc.
Treatment for: Overactive Bladder

Marketing Status: Discontinued

Anturol (oxybutynin) is an anticholinergic transdermal gel formulation indicated for the management of overactive bladder.

• Anturol Approved by FDA for the Treatment of Overactive Bladder
• Anturol (oxybutynin) FDA Approval History

Edarbyclor (azilsartan medoxomil and chlorthalidone) Tablets

Date of Approval: December 20, 2011
Company: Azurity Pharmaceuticals, Inc.
Treatment for: High Blood Pressure

Edarbyclor (azilsartan medoxomil and chlorthalidone) is a fixed-dose combination of an angiotensin II receptor blocker (ARB) and a diuretic, indicated for the treatment of hypertension.

• FDA Approves Edarbyclor (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
• Edarbyclor (azilsartan medoxomil and chlorthalidone) FDA Approval History

Eylea (aflibercept) Injection

Date of Approval: November 18, 2011
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Macular Degeneration, Macular Edema, Diabetic Retinopathy, Diabetic Macular Edema, Retinopathy of Prematurity

Eylea (aflibercept) is a VEGF inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and retinopathy of prematurity.

• Eylea (aflibercept) Injection Receives FDA Approval for Macular Edema Following Retinal Vein Occlusion (RVO)
• Eylea (aflibercept) FDA Approval History