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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Aveed (testosterone undecanoate) Intramuscular Injection - formerly Nebido
Company: Endo Pharmaceuticals
Date of Approval: March 5, 2014
Treatment for: Hypogonadism -- Male
Aveed (testosterone undecanoate) is a long-acting androgen depot injection for the treatment of male hypogonadism.
- FDA Approves Aveed (testosterone undecanoate) Injectable Testosterone Replacement Therapy - March 6, 2014
- FDA Accepts Endo's Complete Response Submission to New Drug Application for Aveed (Testosterone Undecanoate) Injection - September 5, 2013
- Endo Pharmaceuticals Provides Regulatory Update On Aveed (Testosterone Undecanoate) Injection - May 31, 2013
- Endo Pharmaceuticals Provides Regulatory Update on Aveed (Testosterone Undecanoate) Injection - December 3, 2009
- Endo Pharmaceuticals Gives Update on Regulatory Status of Testosterone Undecanoate for Men with Hypogonadism - September 3, 2009
- FDA Accepts Complete Response Submission to New Drug Application for Nebido - March 12, 2009
- Indevus and FDA Agree on Path Forward for Nebido - September 26, 2008
- Indevus Receives Approvable Letter from FDA for Nebido - June 30, 2008
- Indevus Pharmaceuticals Provides Update on Nebido NDA Status - June 4, 2008
- FDA Accepts New Drug Application for Nebido Submitted by Indevus - November 1, 2007
- Indevus Announces Submission of New Drug Application for Nebido - August 28, 2007
Myalept (metreleptin) Injection
Company: Amylin Pharmaceuticals, Inc.
Date of Approval: February 24, 2014
Treatment for: Lipodystrophy
Myalept (metreleptin) is a leptin analog indicated to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
- FDA Approves Myalept to Treat Generalized Lipodystrophy - February 25, 2014
- FDA Advisory Committee Votes on Investigational Medicine Metreleptin - December 12, 2013
- Amylin Completes Biologics License Application for Metreleptin to Treat Diabetes and/or Hypertriglyceridemia in Patients With Rare Forms of Lipodystrophy - April 3, 2012
- Amylin Submits Clinical and Nonclinical Sections of Rolling Biologics License Application for Metreleptin to Treat Rare Forms of Lipodystrophy - December 20, 2010
Tivorbex (indomethacin) Capsules
Company: Iroko Pharmaceuticals, LLC
Date of Approval: February 24, 2014
Treatment for: Pain
Tivorbex (indomethacin) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of mild to moderate acute pain.
- Iroko Pharmaceuticals Receives FDA Approval for Tivorbex - February 25, 2014
Monovisc (sodium hyaluronate) Injection
Company: Anika Therapeutics, Inc.
Date of Approval: February 24, 2014
Treatment for: Osteoarthritis
Monovisc (sodium hyaluronate) is a viscoelastic supplement indicated for the treatment of pain associated with osteoarthritis of the knee.
- FDA Approves Monovisc, a New Single Injection Treatment for Pain Due to Osteoarthritis of the Knee - February 27, 2014
Northera (droxidopa) Capsules
Company: Chelsea Therapeutics International, Ltd.
Date of Approval: February 18, 2014
Treatment for: Neurogenic Orthostatic Hypotension
Northera (droxidopa) is an orally active synthetic precursor of norepinephrine indicated for the treatment of neurogenic orthostatic hypotension.
- FDA Approves Northera to treat Neurogenic Orthostatic Hypotension - February 18, 2014
- Chelsea Therapeutics Issues Statement Regarding Postponement of Northera NDA PDUFA Date - February 14, 2014
- FDA Advisory Panel Recommends Approval of Chelsea Therapeutics' Northera (Droxidopa) for the Treatment of Symptomatic nOH - January 14, 2014
- Chelsea Therapeutics Announces FDA Advisory Committee to Review Northera - October 9, 2013
- Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission - September 4, 2013
- Chelsea Therapeutics Announces Submission of Additional Information for Northera NDA - August 15, 2013
- Chelsea Therapeutics Announces FDA Acceptance of Northera (droxidopa) NDA Resubmission - July 17, 2013
- Chelsea Therapeutics Resubmits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH - July 9, 2013
- Chelsea Therapeutics Receives FDA Guidance for a Northera (Droxidopa) NDA Resubmission With Study 306B - February 20, 2013
- Chelsea Therapeutics Provides an Update on Northera (droxidopa) Regulatory Status and Development Program - July 3, 2012
- Chelsea Therapeutics Completes End-of-Review Meeting With FDA for Northera (droxidopa) NDA - May 22, 2012
- Chelsea Therapeutics Receives Complete Response Letter from Food and Drug Administration for Northera (droxidopa) Capsules - March 28, 2012
- FDA Advisory Panel Recommends Approval of Chelsea's Northera (droxidopa) for the Treatment of Symptomatic Neurogenic OH - February 24, 2012
- Chelsea Therapeutics CEO to Review Northera NDA and Provide an Update on Upcoming Advisory Committee Meeting During Presentation at BIO CEO - February 14, 2012
- Chelsea Therapeutics Announces FDA Advisory Committee Meeting Date for Review of Northera NDA for the Treatment of Symptomatic NOH - January 5, 2012
- Chelsea Therapeutics Submits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH - September 28, 2011
- Chelsea Therapeutics Accelerates Northera NDA Filing Following Meeting With FDA - December 20, 2010
- Chelsea Therapeutics Announces Advancements in Neurogenic Orthostatic Hypotension Registration Program - February 9, 2010
Vimizim (elosufase alfa) Injection
Company: BioMarin Pharmaceutical Inc.
Date of Approval: February 14, 2014
Treatment for: Mucopolysaccharidosis Type IVA
Vimizim (elosufase alfa) is an enzyme replacement therapy for patients with Mucopolysaccharidosis Type IVA (Morquio A syndrome).
- FDA Approves Vimizim to Treat Mucopolysaccharidosis Type IVA - February 16, 2014
- FDA Advisory Committee Recommends Approval of Vimizim for Morquio A Syndrome - November 20, 2013
Hetlioz (tasimelteon) Capsules
Company: Vanda Pharmaceuticals Inc.
Date of Approval: January 31, 2014
Treatment for: Non-24-Hour Disorder
Hetlioz (tasimelteon) is a melatonin receptor agonist for the treatment of Non-24-Hour Disorder in the totally blind.
- FDA Approves Hetlioz: First Treatment for Non-24 Hour Sleep-Wake Disorder in Blind Individuals - January 31, 2014
- FDA Advisory Committee Recommends Approval of Hetlioz for the Treatment of Non-24-Hour-Disorder (Non-24) in the Totally Blind - November 15, 2013
- Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind - May 31, 2013
Farxiga (dapagliflozin) Tablets
Company: Bristol-Myers Squibb Company and AstraZeneca
Date of Approval: January 8, 2014
Treatment for: Diabetes Type 2
Farxiga (dapagliflozin) is a selective sodium-glucose cotransporter-2 inhibitor for the treatment of adults with type 2 diabetes mellitus.
- FDA Approves Farxiga to Treat Type 2 Diabetes - January 8, 2014
- FDA Advisory Committee Recommends the Investigational SGLT2 Inhibitor Dapagliflozin for Treatment of Type 2 Diabetes in Adults - December 12, 2013
- AstraZeneca and Bristol-Myers Squibb resubmit Dapagliflozin New Drug Application for the treatment of type 2 diabetes in the U.S - July 25, 2013
- Bristol-Myers Squibb and AstraZeneca Receive Complete Response Letter from U.S. Food and Drug Administration for Dapagliflozin - January 19, 2012
- U.S. Food and Drug Administration Extends Action Date for Dapagliflozin by Three Months - October 27, 2011
- FDA Advisory Committee Makes Recommendation on Investigational Compound Dapagliflozin - July 20, 2011
- FDA Accepts New Drug Application for Investigational Compound Dapagliflozin for the Treatment of Type 2 Diabetes - March 8, 2011
Tretten (coagulation factor XIII A-subunit (recombinant))
Company: Novo Nordisk A/S
Date of Approval: December 23, 2013
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 - December 23, 2013
Orenitram (treprostinil) Extended-Release Tablets
Company: United Therapeutics Corporation
Date of Approval: December 20, 2013
Treatment for: Pulmonary 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 - December 30, 2013
- United Therapeutics Announces FDA Acceptance of Second Resubmission of Oral Treprostinil NDA - September 12, 2013
Anoro Ellipta (umeclidinium bromide and vilanterol)
Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Date of Approval: December 18, 2013
Treatment for: Chronic Obstructive Pulmonary Disease
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 - December 18, 2013
- FDA Advisory Committee to Review Anoro Ellipta NDA - September 10, 2013
- FDA Advisory Committee Recommends Approval in U.S. of Umeclidinium/Vilanterol for the Treatment of COPD - September 10, 2013
- Theravance Announces FDA Advisory Committee to Review Anoro Ellipta (UMEC/VI) for COPD - August 2, 2013
- GSK and Theravance Announce FDA Acceptance of New Drug Application Submission in the US for Anoro Ellipta for COPD - February 19, 2013
Sovaldi (sofosbuvir) Tablets
Company: Gilead Sciences
Date of Approval: December 6, 2013
Treatment for: Chronic Hepatitis C
Sovaldi (sofosbuvir) is a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection.
- FDA Approves Sovaldi for Chronic Hepatitis C - December 6, 2013
- FDA Advisory Committee Supports Approval of Gilead’s Sofosbuvir for Chronic Hepatitis C Infection - October 25, 2013
- Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C - June 7, 2013
- Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C - April 9, 2013
Velphoro (sucroferric oxyhydroxide) Chewable Tablets
Company: Vifor Fresenius Medical Care Renal Pharma
Date of Approval: November 27, 2013
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 - November 30, 2013
Varithena (polidocanol) Injectable Foam
Company: BTG plc
Date of Approval: November 25, 2013
Treatment for: Varicose Vein
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 - November 26, 2013
Olysio (simeprevir) Capsules
Company: Janssen Research & Development, LLC
Date of Approval: November 22, 2013
Treatment for: Chronic 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 - November 24, 2013
- FDA Advisory Committee Recommends Approval of Simeprevir for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients - October 24, 2013
- U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C - May 13, 2013
- Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C - March 29, 2013
Luzu (luliconazole) Topical Cream
Company: Valeant Pharmaceuticals International, Inc.
Date of Approval: November 14, 2013
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% - November 15, 2013
Imbruvica (ibrutinib) Capsules
Company: Janssen Research & Development, LLC
Date of Approval: November 13, 2013
Treatment for: Mantle Cell Lymphoma
Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.
- FDA Approves Imbruvica to Treat Chronic Lymphocytic Leukemia - February 12, 2014
- FDA Approves Imbruvica for Mantle Cell Lymphoma - November 13, 2013
- New Drug Application Filing for Ibrutinib Accepted in Two B-cell Malignancies by the U.S. FDA - August 29, 2013
- New Drug Application Submitted to U.S. FDA for Ibrutinib in the Treatment of Two B-Cell Malignancies - July 10, 2013
Aptiom (eslicarbazepine acetate) Tablets - formerly Stedesa
Company: Sunovion Pharmaceuticals Inc.
Date of Approval: November 8, 2013
Treatment for: Epilepsy, Seizures
Aptiom (eslicarbazepine acetate) is a voltage-gated sodium channel blocker for the treatment of partial-onset seizures in adults with epilepsy.
- FDA Approves Aptiom to Treat Seizures in Adults - November 8, 2013
- Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for Stedesa (eslicarbazepine acetate) as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy - March 8, 2013
- FDA Provides Complete Response to Sepracor's New Drug Application for Stedesa - May 4, 2010
- FDA Extends PDUFA Action Date for Stedesa New Drug Application - January 29, 2010
- Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA - June 1, 2009
- Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy - March 31, 2009
Gazyva (obinutuzumab) Injection
Company: Genentech
Date of Approval: November 1, 2013
Treatment for: Chronic Lymphocytic Leukemia
Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated, in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.
- FDA Approves Gazyva for Chronic Lymphocytic Leukemia - November 1, 2013
Zohydro ER (hydrocodone) Extended-Release Capsules
Company: Zogenix, Inc.
Date of Approval: October 25, 2013
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 - October 25, 2013
- Zogenix Provides Update on Zohydro ER Regulatory Review - February 27, 2013
- Zogenix Provides Update on FDA Advisory Committee Meeting for Zohydro ER for Management of Chronic Pain - December 10, 2012
- Zogenix Announces FDA Advisory Committee Review of Zohydro ER for the Management of Chronic Pain - November 16, 2012
- Zogenix Announces U.S. Food and Drug Administration (FDA) Acceptance for Review of Zohydro ER New Drug Application (NDA) for Treatment of Chronic Pain - July 16, 2012
- Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro for Treatment of Chronic Pain - May 2, 2012
