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 5, 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: 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: 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 ages 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
- 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
Date of Approval: August 19, 2009
Company: GlaxoSmithKline
Treatment for: Haemophilus influenzae Prophylaxis
Hiberix is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children 15 months through 4 years of age (prior to fifth birthday).
- FDA Approves GSK's Hib Vaccine, Hiberix - August 20, 2009
Date of Approval: August 14, 2009
Treatment for: Multiple Sclerosis
Extavia is a branded version of interferon beta-1b, a first-line disease-modifying therapy that has been a standard-of-care for multiple sclerosis for many years. Extavia is indicated for the treatment of MS patients with relapsing forms of the disease and for newly diagnosed patients.
- US FDA Approves Extavia - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with This Devastating Disease - August 17, 2009
FDA Drug Approvals Archive
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