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, New Drug Applications, Recent Additions to Drugs.com, Approval Process, New Indications and Dosage forms
Latest New Drug Approvals
Date of Approval: November 16, 2009
Company: NeurogesX, Inc.
Treatment for: Postherpetic Neuralgia
Qutenza, formerly NGX-4010, is a capsaicin transdermal patch for the management of pain due to postherpetic neuralgia.
- NeurogesX Receives FDA Approval of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN) - November 16, 2009
- NeurogesX Announces New PDUFA Date for Qutenza New Drug Application - August 6, 2009
- NeurogesX Provides U.S. Regulatory Update for Qutenza - June 10, 2009
- NeurogesX Announces FDA Acceptance to Review New Drug Application for NGX-4010 to Treat Post-Herpetic Neuralgia - December 19, 2008
- NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN) - October 22, 2008
Date of Approval: November 13, 2009
Company: Xanodyne Pharmaceuticals, Inc.
Treatment for: Menorrhagia
Lysteda (tranexamic acid) is an antifibrinolytic agent for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms.
- Xanodyne Announces FDA Approval of Lysteda (Tranexamic Acid) for Treatment of Women with Heavy Menstrual Bleeding - November 16, 2009
- Xanodyne's New Drug Application for XP12B the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification - April 2, 2009
Date of Approval: November 5, 2009
Company: Gloucester Pharmaceuticals
Treatment for: Cutaneous T-cell Lymphoma
Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma.
- FDA Approves Gloucester Pharmaceuticals' Istodax for Patients with Cutaneous T-cell Lymphoma - November 6, 2009
- FDA Advisory Committee Recommends Gloucester Pharmaceuticals' Romidepsin for Approval for Cutaneous T-cell Lymphoma - September 2, 2009
- Gloucester Pharmaceuticals Announces FDA Advisory Committee Meeting to Discuss Romidepsin New Drug Application - August 18, 2009
Date of Approval: November 4, 2009
Company: Nuvo Research Inc.
Treatment for: Osteoarthritis
Pennsaid is a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee.
- FDA Approves Pennsaid Topical Solution - November 5, 2009
- FDA Extends Review of Pennsaid Diclofenac Sodium Topical Solution - August 5, 2009
- FDA Accepts Nuvo's Resubmission For Pennsaid - February 19, 2009
- Nuvo Provides Update on Discussions with the FDA Related to Pennsaid Approval - June 19, 2007
- Nuvo Continues Discussions with the FDA Related to Pennsaid - June 6, 2007
- Nuvo announces further update on discussions with the FDA related to review of Pennsaid - March 7, 2007
- Nuvo Announces Update on Discussions With FDA Related to Approval of Pennsaid - February 9, 2007
- Nuvo Receives Approvable Letter From U.S. FDA for Pennsaid - December 29, 2006
- Nuvo’s Pennsaid NDA Resubmission Accepted for Review by U.S. FDA - July 13, 2006
Date of Approval: October 26, 2009
Company: GlaxoSmithKline
Treatment for: Chronic Lymphocytic Leukemia
Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.
- FDA Approves Arzerra (ofatumumab) for Chronic Lymphocytic Leukemia - October 26, 2009
- FDA Extends Review of Arzerra (ofatumumab) - June 16, 2009
- GSK/Genmab Receive Favorable Recommendation for Arzerra from FDA Advisory Panel - May 29, 2009
- FDA Advisory Committee to Review Arzerra (Ofatumumab) - May 4, 2009
- Arzerra (Ofatumumab) Granted Priority Review By FDA - April 3, 2009
- GlaxoSmithKline and Genmab Submit Arzerra (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer - January 30, 2009
Date of Approval: October 19, 2009
Company: GlaxoSmithKline
Treatment for: Renal Cell Carcinoma
Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.
- FDA Approves GlaxoSmithKline’s Votrient for Advanced Renal Cell Cancer - October 19, 2009
- GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for Votrient - October 5, 2009
Date of Approval: October 16, 2009
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: Hypertension
Twynsta (telmisartan/amlodipine) is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension alone or with other antihypertensive agents.
- FDA Approves Twynsta (telmisartan/amlodipine) for Hypertension - October 19, 2009
Date of Approval: October 16, 2009
Company: GlaxoSmithKline
Treatment for: Human Papillomavirus Prophylaxis
Cervarix (human papillomavirus bivalent (types 16 and 18) is a is a preventative cervical cancer vaccine for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 in girls and young women (aged 10-25).
- FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine - October 16, 2009
- FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine - September 9, 2009
- Cervarix U.S. Regulatory Update - March 30, 2009
- GlaxoSmithKline Responds to FDA on Cervarix and Plans to Submit Final Study Data for Approval - June 30, 2008
- GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervarix Cervical Cancer Vaccine - December 17, 2007
- GlaxoSmithKline Submits Biologics License Application to U.S. Food and Drug Administration for Cervarix - March 29, 2007
Date of Approval: October 9, 2009
Company: CSL Behring
Treatment for: Angioedema
Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 Esterase Inhibitor indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.
- CSL Behring Announces FDA Approval of Berinert, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S. - October 12, 2009
- CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema - March 6, 2008
Date of Approval: September 25, 2009
Company: Centocor Ortho Biotech Inc.
Treatment for: Psoriasis
Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis.
- FDA Approves Stelara (ustekinumab) to Treat Psoriasis - September 25, 2009
- FDA Extends Review Timeline for Stelara (ustekinumab) Biologic License Application by Three Months - May 27, 2009
- FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application - December 19, 2008
- FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months - August 8, 2008
- FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis - June 18, 2008
- Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA - February 4, 2008
- Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis - December 7, 2007
- Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis - December 4, 2007
Date of Approval: September 24, 2009
Company: Allos Therapeutics, Inc.
Treatment for: Peripheral T-cell Lymphoma
Folotyn (pralatrexate) is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
- FDA Approves Folotyn (pralatrexate) for Treatment of Peripheral T-cell Lymphoma - September 25, 2009
- Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of Folotyn (pralatrexate) for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma - September 3, 2009
- Allos Therapeutics Announces FDA Advisory Committee to Review Pralatrexate for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma - August 11, 2009
- Allos Therapeutics Submits New Drug Application for Pralatrexate for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma - March 25, 2009
Date of Approval: September 16, 2009
Company: Novartis
Treatment for: Hypertension
Valturna is a combination of aliskiren (a direct renin inhibitor) and valsartan (an angiotensin II receptor blocker) indicated for the treatment of high blood pressure.
- Novartis receives FDA approval for Valturna, a single-pill combination of valsartan and aliskiren, to treat high blood pressure - September 17, 2009
Date of Approval: September 15, 2009
Company: Sirion Therapeutics, Inc.
Treatment for: Herpetic Keratitis
Zirgan (ganciclovir ophthalmic gel) is a topical ophthalmic antiviral preparation for the treatment of acute herpetic keratitis (dendritic ulcers).
- Sirion Therapeutics Announces FDA Approval of Zirgan (ganciclovir ophthalmic gel) 0.15% for Herpetic Keratitis - September 16, 2009
- Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes - January 26, 2009
Date of Approval: September 15, 2009
Company: CSL Limited; Novartis Vaccines and Diagnostics Limited; Sanofi Pasteur, Inc.; MedImmune LLC
Treatment for: Prevention of H1N1 Influenza
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
- FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children - November 13, 2009
- FDA Approves Vaccines for 2009 H1N1 Influenza Virus - September 16, 2009
Date of Approval: September 11, 2009
Company: Theravance Inc.
Treatment for: Complicated Skin and Skin Structure Infections (cSSSI)
Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.
- Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections - September 13, 2009
- FDA Accepts for Review Theravance's Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - April 25, 2009
- Theravance Announces FDA Acceptance of Telavancin NDA for the Treatment of Hospital-Acquired Pneumonia - April 7, 2009
- Theravance Receives Complete Response Letter on the Telavancin New Drug Application for the Treatment of cSSSI - February 27, 2009
- Theravance Submits U.S. NDA for Telavancin for the Treatment of Hospital-Acquired Pneumonia - January 27, 2009
- Theravance Reports Favorable Outcome of FDA Advisory Committee Meeting on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - November 20, 2008
- FDA Accepts for Review Theravance's Complete Response to Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - March 6, 2008
- Theravance Receives Notice of Possible Telavancin Review by FDA Advisory Committee - January 2, 2008
Date of Approval: September 8, 2009
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Allergic Conjunctivitis
Bepreve (bepotastine ophthalmic solution) is an antihistamine and mast cell stabilizer for treatment of the symptoms of allergic conjunctivitis.
- Ista Pharmaceuticals' Bepreve Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies - September 9, 2009
- Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis - June 28, 2009
- ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis - June 2, 2009
- ISTA Pharmaceuticals' New Drug Application for Bepreve Accepted for Review by U.S. Food and Drug Administration - January 15, 2009
- ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve - November 14, 2008
Date of Approval: September 4, 2009
Company: Salix Pharmaceuticals, Ltd.
Treatment for: Gastroesophageal Reflux Disease, Gastroparesis
Metozolv ODT is a fast–dissolving formulation of metoclopramide for the short–term treatment of adults with gastroesophageal reflux and for the relief of symptoms associated with diabetic gastroparesis.
- Salix Receives FDA Marketing Approval for Metozolv ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD - September 8, 2009
- Salix Announces FDA Complete Response Letter for Metozolv ODT - February 27, 2009
- FDA Extends Metozolv ODT Review Date - November 18, 2008
Date of Approval: September 2, 2009
Company: Shire plc
Treatment for: Attention-Deficit Hyperactivity Disorder
Intuniv (guanfacine) is a nonstimulant selective alpha-2A-receptor agonist for the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
- Shire Announces FDA Approval of Once-Daily Intuniv (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17 - September 3, 2009
- FDA Issues Complete Response Letter for Intuniv (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents - July 28, 2009
- Shire Receives Approvable Letter From FDA for Intuniv (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD - June 21, 2007
- Shire Announces NDA Submission of Guanfacine Extended Release for the Treatment of ADHD in Children and Adolescents - August 24, 2006
Date of Approval: August 27, 2009
Company: Eurand Pharmaceuticals Ltd.
Treatment for: Pancreatic Exocrine Dysfunction
Zenpep (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.
- Eurand Granted FDA Approval for Zenpep - August 28, 2009
- Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase) - June 19, 2008
- Eurand Granted Priority Review for Zentase NDA - February 21, 2008
- Eurand Completes New Drug Application for Zentase - December 20, 2007
- Eurand Files NDA for Zentase for Exocrine Pancreatic Insufficiency - June 12, 2007
Date of Approval: August 21, 2009
Company: Lundbeck Inc.
Treatment for: Epilepsy, Seizures
Sabril (vigabatrin) is an oral irreversible GABA-transaminase inhibitor for the treatment of Infantile Spasms and refractory complex partial seizures.
- Lundbeck Inc. Announces FDA Marketing Approval for Sabril for the Treatment of Two Difficult-to-Treat Epilepsies - August 21, 2009
- FDA Advisory Committee Unanimously Recommends Sabril (vigabatrin) for the Treatment of Two Catastrophic Epilepsies - January 9, 2009
- FDA Accepts for Review Ovation's Two NDA Submissions for Sabril - February 27, 2008
FDA Drug Approvals Archive
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