New Drug Approvals
The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.
See also: Generic Approvals, Approval Process, New Indications and Dosage forms
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Company: Sanofi Pasteur Inc.
Date of Approval: February 7, 2012
Treatment for: Lice
Sklice (ivermectin) Lotion is a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older.
- Sanofi Announces FDA Approval of Sklice Lotion for the Treatment of Head Lice - February 7, 2012
- Topaz Pharmaceuticals Announces New Drug Application for the Treatment of Head Lice Accepted by FDA - June 15, 2011
Company: Vertex Pharmaceuticals Incorporated
Date of Approval: January 31, 2012
Treatment for: Cystic Fibrosis
Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.
- FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis - January 31, 2012
- FDA Grants Priority Review for Kalydeco (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis - December 15, 2011
- Vertex Submits Application for Priority Review and Approval of Kalydeco (VX-770, ivacaftor) in the U.S. as First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis - October 26, 2011
Company: Genentech
Date of Approval: January 30, 2012
Treatment for: Basal Cell Carcinoma
Erivedge (vismodegib) is a hedgehog pathway inhibitor for the treatment of patients with advanced basal cell carcinoma (BCC).
- FDA Approves Erivedge for Basal Cell Carcinoma - January 30, 2012
- FDA Accepts Genentech's New Drug Application For Vismodegib in Advanced Form of Skin Cancer - November 9, 2011
- Genentech Submits New Drug Application to FDA for Vismodegib for Rare Form of Advanced Skin Cancer - September 12, 2011
Company: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly
Date of Approval: January 30, 2012
Treatment for: Diabetes Mellitus Type II
Jentadueto (linagliptin and metformin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes - February 1, 2012
Company: Amylin Pharmaceuticals, Inc. and Alkermes plc
Date of Approval: January 27, 2012
Treatment for: Diabetes Mellitus Type II
Bydureon (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
- FDA Approves Bydureon - The First and Only Once-Weekly Treatment for Type 2 Diabetes - January 27, 2012
- Bydureon FDA Action Date Set for January 28, 2012 - August 10, 2011
- Bydureon Reply Submitted to FDA - July 28, 2011
- Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for Bydureon - October 20, 2010
- Bydureon FDA Review Timeline Set with PDUFA Action Date of October 22, 2010 - May 6, 2010
- Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for Bydureon - April 23, 2010
Company: Pfizer Inc.
Date of Approval: January 27, 2012
Treatment for: Renal Cell Carcinoma
Inlyta (axitinib) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
- FDA Approves Inlyta for Advanced Renal Cell Carcinoma - January 27, 2012
- FDA Advisory Committee Finds The Benefit/Risk Profile Of Axitinib In Previously Treated Advanced Renal Cell Carcinoma (RCC) To Be Favorable - December 7, 2011
- Pfizer Files With The FDA For Review Of Axitinib For Patients With Advanced Renal Cell Carcinoma - July 7, 2011
Company: Leo Pharma
Date of Approval: January 23, 2012
Treatment for: Actinic Keratosis
Picato (ingenol mebutate) is an inducer of cell death indicated for the topical treatment of actinic keratosis.
- FDA Approves Picato (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing - January 25, 2012
Company: Sunovion Pharmaceuticals Inc.
Date of Approval: January 20, 2012
Treatment for: Allergic Rhinitis
Zetonna (ciclesonide) is corticosteroid nasal spray indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis.
- FDA Approves Zetonna (ciclesonide) Nasal Aerosol for Allergic Rhinitis - January 24, 2012
Company: BTG International Inc.
Date of Approval: January 17, 2012
Treatment for: Toxic Methotrexate Levels
Voraxaze (glucarpidase) is a carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate levels in patients with delayed methotrexate clearance due to impaired renal function.
- FDA Approves Voraxaze to Treat Patients with Toxic Methotrexate Levels - January 17, 2012
- Protherics PLC Voraxaze Rolling BLA Submission Initiated with the US FDA - November 20, 2008
Company: INSYS Therapeutics, Inc.
Date of Approval: January 4, 2012
Treatment for: Pain
Subsys (fentanyl) is an opioid analgesic sublingual spray formulation indicated for the treatment of breakthrough cancer pain.
- Insys Therapeutics Announces FDA Approval of Subsys Fentanyl Sublingual Spray - January 5, 2012
- INSYS Announces NDA PDUFA Date for Fentanyl SL Spray - May 21, 2011
Company: Takeda Pharmaceutical Company Limited
Date of Approval: December 20, 2011
Treatment for: Hypertension
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 - December 20, 2011
Company: Antares Pharma, Inc.
Date of Approval: December 7, 2011
Treatment for: Overactive Bladder
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 - December 8, 2011
- Antares Pharma Announces FDA Acceptance of Anturol NDA for Filing - April 8, 2011
- Antares Pharma Announces Filing of New Drug Application for Anturol for Overactive Bladder - December 22, 2010
Company: Transcept Pharmaceuticals, Inc.
Date of Approval: November 23, 2011
Treatment for: Insomnia
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 - November 23, 2011
- Transcept Pharmaceuticals Announces Intermezzo PDUFA Action Date of November 27, 2011 - October 7, 2011
- Transcept Pharmaceuticals Announces Plan to Resubmit Intermezzo New Drug Application Following Meeting with the U.S. Food & Drug Administration - September 14, 2011
- Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application - July 15, 2011
- Transcept Pharmaceuticals Expects Complete Response Letter on Intermezzo New Drug Application Based on Teleconference with FDA - July 13, 2011
- Transcept Pharmaceuticals Resubmits Intermezzo New Drug Application for the Treatment of Middle of the Night Awakenings - January 19, 2011
- Transcept Pharmaceuticals Updates Plan for Intermezzo NDA Resubmission Following Teleconference With the FDA - March 25, 2010
- Transcept Pharmaceuticals Provides Update on Intermezzo Regulatory Review - February 23, 2010
- Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo Complete Response Letter - November 24, 2009
- Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application - October 30, 2009
- Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo - June 11, 2009
- Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo - December 16, 2008
- Transcept Pharmaceuticals Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings - October 1, 2008
Company: EUSA Pharma, Inc.
Date of Approval: November 18, 2011
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 - November 18, 2011
- EUSA Pharma Submits Erwinase Biologics License Application (BLA) for Treatment of Acute Lymphoblastic Leukemia - November 9, 2010
Company: Regeneron Pharmaceuticals, Inc.
Date of Approval: November 18, 2011
Treatment for: Macular Degeneration
Eylea (aflibercept) is a VEGF inhibitor for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD).
- FDA Approves Eylea for Wet Age-Related Macular Degeneration - November 18, 2011
- Regeneron Announces Review of Biologics License Application for Eylea (aflibercept injection) Extended by Three Months by FDA - August 17, 2011
- Regeneron Announces Eylea (aflibercept ophthalmic solution) Receives Unanimous Recommendation for Approval for Treatment of Wet AMD from FDA Advisory Committee - June 17, 2011
Company: Merz Pharmaceuticals, LLC
Date of Approval: November 16, 2011
Treatment for: Glabellar Lines
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 - November 16, 2011
- Merz Pharmaceuticals' Belotero Balance PMA Filing Formally Accepted for Review by the FDA - September 11, 2009
Company: Incyte Corporation
Date of Approval: November 16, 2011
Treatment for: Myelofibrosis
Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of patients with myelofibrosis.
- FDA Approves Jakafi to Treat Myelofibrosis - November 16, 2011
- FDA Accepts NDA Filing for Ruxolitinib as a Treatment for Myelofibrosis - August 3, 2011
- Incyte Submits New Drug Application for Ruxolitinib in Myelofibrosis to the US Food and Drug Administration - June 8, 2011
Company: IntelGenx Corp.
Date of Approval: November 10, 2011
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 - November 11, 2011
Company: Pacira Pharmaceuticals, Inc.
Date of Approval: October 28, 2011
Treatment for: Pain
Exparel (bupivacaine liposome injectable suspension) is a long-acting non-opioid local analgesic for the management of postsurgical pain.
- Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of Exparel For Postsurgical Pain Management - October 31, 2011
- Pacira Pharmaceuticals, Inc. Announces FDA Extension of Exparel PDUFA Target Date By Three Months - June 14, 2011
- Pacira Pharmaceuticals Announces FDA Acceptance of Exparel New Drug Application for Pain Management - December 14, 2010
Company: Lundbeck Inc.
Date of Approval: October 21, 2011
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 - October 24, 2011
- FDA Accepts Lundbeck Inc. Submission of New Drug Application for Clobazam - March 4, 2011
- H. Lundbeck A/S (DK) - Lundbeck will submit an NDA for clobazam for patients with Lennox-Gastaut syndrome with the FDA before year end 2010 - June 11, 2010
