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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Fabior (tazarotene) Foam
Company: Stiefel Laboratories, Inc.
Date of Approval: May 11, 2012
Treatment for: Acne
Fabior (tazarotene) Foam is a retinoid indicated for the topical treatment of acne vulgaris.
- Stiefel Receives US FDA Approval of Fabior Foam, 0.1% - May 14, 2012
Elelyso (taliglucerase alfa) - formerly Uplyso
Company: Protalix BioTherapeutics, Inc.
Date of Approval: May 1, 2012
Treatment for: Gaucher Disease
Elelyso (taliglucerase alfa) is a plant-cell expressed recombinant form of glucocerebrosidase for the treatment of Gaucher disease.
- FDA Approves New Orphan Drug Elelyso to Treat a Form of Gaucher Disease - May 1, 2012
- FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012 - December 15, 2011
- Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date - August 24, 2011
- Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date - August 17, 2011
- Protalix Submits Reply to FDA Complete Response Letter for Taliglucerase Alfa and Reports Top-Line Results from the Company's Switchover Trial - August 1, 2011
- FDA Denies Taliglucerase Alfa New Drug Application - February 25, 2011
- Protalix BioTherapeutics Receives PDUFA Date for taliglucerase alfa - July 12, 2010
- Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease - February 2, 2010
- Protalix Completes NDA Submission for taliglucerase alfa for the Treatment of Gaucher's Disease - December 10, 2009
- U.S. Food and Drug Administration Approves Protalix's Treatment Protocol for prGCD - August 17, 2009
- Protalix Holds Pre-NDA Meeting with FDA for prGCD - July 14, 2009
Dymista (azelastine and fluticasone) Nasal Spray
Company: Meda Pharmaceuticals, Inc.
Date of Approval: May 1, 2012
Treatment for: Allergic Rhinitis
Dymista (azelastine and fluticasone) nasal spray is an H1-receptor antagonist and corticosteroid combination indicated for the relief of symptoms of seasonal allergic rhinitis.
- MEDA Announces Dymista Approved by the FDA - May 2, 2012
Stendra (avanafil) Tablets
Company: Vivus, Inc.
Date of Approval: April 27, 2012
Treatment for: Erectile Dysfunction
Stendra (avanafil) is a phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED).
- FDA Approves Stendra for Erectile Dysfunction - April 27, 2012
- VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction - September 2, 2011
- VIVUS Submits New Drug Application for Avanafil for the Treatment of Erectile Dysfunction - June 30, 2011
Amyvid (florbetapir F 18) Injection
Company: Eli Lilly and Company and Avid Radiopharmaceuticals, Inc.
Date of Approval: April 6, 2012
Treatment for: Diagnostic
Amyvid (florbetapir F 18) is a radioactive diagnostic agent used for brain imaging of beta-amyloid plaques in patients who are being evaluated for Alzheimer's Disease and other causes of cognitive decline.
- FDA Approves Amyvid (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline - April 9, 2012
- Lilly and Avid Receive Complete Response Letter from FDA for Amyvid (florbetapir F 18 injection) - March 18, 2011
Omontys (peginesatide) Injection - formerly Hematide
Company: Affymax, Inc. and Takeda Pharmaceutical Company Limited
Date of Approval: March 27, 2012
Treatment for: Anemia Associated with Chronic Renal Failure
Omontys (peginesatide) an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
- Affymax and Takeda Announce FDA Approval of Omontys (peginesatide) Injection for the Treatment of Anemia Due to Chronic Kidney Disease (CKD) in Adult Patients on Dialysis - March 27, 2012
- FDA Advisory Committee Voted in Favor of Benefit/Risk Profile for Peginesatide for Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis - December 8, 2011
- Affymax Announces FDA Advisory Committee to Review Peginesatide - October 24, 2011
- Affymax Announces Assignment of March 27, 2012 PDUFA Date for Peginesatide New Drug Application - August 11, 2011
- Affymax and Takeda Announce FDA Acceptance of New Drug Application for Peginesatide - August 5, 2011
- Affymax and Takeda Announce the Submission of a New Drug Application for Peginesatide for the Treatment of Anemia Associated with Chronic Renal Failure in Patients on Dialysis - May 31, 2011
- Affymax and Takeda Confirm U.S. Registration Strategy for Investigational Drug, Hematide/peginesatide, Following Meeting with FDA - November 29, 2010
QNASL (beclomethasone dipropionate) Nasal Aerosol - formerly BDP Nasal HFA
Company: Teva Pharmaceutical Industries Ltd.
Date of Approval: March 23, 2012
Treatment for: Allergic Rhinitis
QNASL (beclomethasone dipropionate) is an intranasal corticosteroid non-aqueous "dry" spray formulation for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).
- Teva Announces FDA Approval of QNASL (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis - March 26, 2012
- Teva Receives FDA Acceptance of Its New Drug Application for BDP Nasal HFA for the Treatment of Allergic Rhinitis - August 8, 2011
Binosto (alendronate) Effervescent Tablets - formerly EX101
Company: EffRx Pharmaceuticals SA
Date of Approval: March 12, 2012
Treatment for: Osteoporosis
Binosto (alendronate) is a buffered effervescent dosage form of the bisphosphonate drug alendronate sodium administered once weekly for the treatment of osteoporosis.
- FDA Approves Binosto, First and Only Effervescent Osteoporosis Treatment in a Buffered Solution - March 15, 2012
- First EffRx NDA Accepted for Filing by the FDA - May 11, 2011
- EffRx Pharmaceuticals SA Announces Submission of New Drug Application to FDA for Osteoporosis Treatment Targeting Increased Convenience for Patients - January 10, 2011
Surfaxin (lucinactant) Intratracheal Suspension
Company: Discovery Laboratories, Inc.
Date of Approval: March 6, 2012
Treatment for: Respiratory Distress Syndrome
Surfaxin (lucinactant) is a synthetic, peptide-containing surfactant indicated for the prevention of respiratory distress syndrome (RDS) in premature infants.
- Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome - March 6, 2012
- Discovery Labs Notified of PDUFA Date for Surfaxin - October 12, 2011
- Discovery Labs Submits Surfaxin Complete Response to FDA - September 6, 2011
- Discovery Labs Provides Expanded Update Regarding Its Program for Surfaxin U.S. Marketing Authorization - February 1, 2011
- Discovery Labs Provides Update Regarding Its Program for Surfaxin U.S. Marketing Authorization - January 10, 2011
- Discovery Labs Receives FDA Guidance Regarding Preclinical Program to Gain Surfaxin Approval - June 8, 2010
- Discovery Labs Achieves Key Milestone Towards Potential Surfaxin Approval - May 19, 2010
- Discovery Labs and FDA Establish Path for Potential Surfaxin Approval - October 2, 2009
- Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval - September 11, 2009
- Discovery Labs Reports On Surfaxin End of Review Meeting With FDA - July 2, 2009
- Discovery Labs and FDA to Meet On June 2, 2009 to Discuss Surfaxin Complete Response Letter - May 12, 2009
- FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin - November 10, 2008
- Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS - October 20, 2008
- Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin - September 24, 2008
- Discovery Labs Reports Progress in Responding to Surfaxin FDA Approvable Letter - August 6, 2008
- Discovery Labs and FDA Meet to Clarify Limited Items in Surfaxin Approvable Letter - June 19, 2008
- Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited Items in Surfaxin Approvable Letter - May 29, 2008
- Discovery Labs Provides Guidance On FDA Approvable Letter for Surfaxin for RDS - May 5, 2008
- Discovery Labs Receives An Approvable Letter From FDA for Surfaxin for RDS - May 2, 2008
- Discovery Labs' Response to Surfaxin Approvable Letter Deemed Complete by FDA - November 16, 2007
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - November 1, 2007
- Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter - October 1, 2007
- Discovery Labs Provides Update On Progress for Surfaxin for RDS - August 2, 2007
- Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval - January 22, 2007
- Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters - September 28, 2006
- Discovery Labs Receives Second Approvable Letter From FDA for Surfaxin for RDS - April 5, 2006
- FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin - October 21, 2005
- Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin - August 19, 2005
- Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin - August 15, 2005
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants - July 29, 2005
- Discovery Labs Receives Approvable Letter from FDA for Surfaxin for Respiratory Distress Syndrome in Premature Infants - February 14, 2005
- Discovery Laboratories Announces FDA Acceptance of Surfaxin New Drug Application - June 15, 2004
- Discovery Laboratories Files New Drug Application with the FDA to Market Surfaxin for the Prevention of Respiratory Distress Syndrome in Premature Infants - April 14, 2004
Ultresa (pancrelipase) Delayed Release Capsules
Company: Aptalis Pharma U.S. Inc.
Date of Approval: March 1, 2012
Treatment for: Pancreatic Exocrine Dysfunction
Ultresa (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
- Aptalis Pharma Announces FDA Approval of Ultresa (Pancrelipase) Delayed Release Capsules - March 1, 2012
Viokace (pancrelipase) Tablets
Company: Aptalis Pharma U.S. Inc.
Date of Approval: March 1, 2012
Treatment for: Pancreatic Exocrine Dysfunction
Viokace (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases. Viokace, in combination with a proton pump inhibitor, is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.
Viokace FDA Approval HistoryKorlym (mifepristone) Tablets
Company: Corcept Therapeutics
Date of Approval: February 17, 2012
Treatment for: Cushing's Syndrome
Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance.
- FDA Approves Korlym for Patients with Endogenous Cushing's Syndrome - February 17, 2012
Bio-T-Gel (testosterone) Topical Gel
Company: BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.
Date of Approval: February 14, 2012
Treatment for: Hypogonadism -- Male
Bio-T-Gel (testosterone) is a once-daily transdermal testosterone gel for the treatment of male hypogonadism or low testosterone levels.
- BioSante Pharmaceuticals Announces FDA Approval for Bio-T-Gel - February 15, 2012
- BioSante Pharmaceuticals Announces Teva New Drug Application for Bio-T-Gel - April 13, 2011
Zioptan (tafluprost) Ophthalmic Solution - formerly Saflutan
Company: Merck & Co., Inc.
Date of Approval: February 10, 2012
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension
Zioptan (tafluprost ophthalmic solution) is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
- FDA Approves Zioptan (tafluprost ophthalmic solution), Merck's Once-Daily, Preservative-Free Ophthalmic Medication - February 13, 2012
- Merck Announces FDA Acceptance of New Drug Application for Investigational Ophthalmic Medication Saflutan (tafluprost) - March 9, 2011
Sklice (ivermectin) Lotion
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
Mitosol (mitomycin) Ophthalmic Solution
Company: Mobius Therapeutics, LLC
Date of Approval: February 7, 2012
Treatment for: Glaucoma Surgery
Mitosol (mitomycin) is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.
Mitosol FDA Approval HistoryKalydeco (ivacaftor) Tablets
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
Erivedge (vismodegib) Capsules
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
Jentadueto (linagliptin and metformin hydrochloride) Tablets
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
Bydureon (exenatide) Extended-Release Injectable Suspension
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
