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: BioSpecifics Technologies Corp.
Date of Approval: February 3, 2010
Treatment for: Dupuytren's Contracture
Xiaflex (collagenase clostridium histolyticum) is a collagenase product for the treatment of Dupuytren's contracture, a condition that affects the connective tissue that lies beneath the skin in the palm.
- Auxilium Announces U.S. Food and Drug Administration Approval for Xiaflex for the Treatment of Dupuytren's Contracture - February 3, 2010
- FDA Advisory Committee Unanimously Recommends Approval of Xiaflex for Treatment of Dupuytren's Disease - September 17, 2009
- BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for Xiaflex for the Treatment of Dupuytren's Disease - April 29, 2009
Company: Labopharm Inc.
Date of Approval: February 2, 2010
Treatment for: Depression
Oleptro (trazodone) is a once-daily serotonin antagonist reuptake inhibitor (SARI) formulation for the treatment of major depressive disorder (MDD) in adults.
- Labopharm Receives FDA Approval for Oleptro - February 3, 2010
- Labopharm's NDA for Novel Trazodone Formulation Accepted for Review by FDA - November 24, 2008
- Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression - September 22, 2008
Company: Novo Nordisk A/S
Date of Approval: January 25, 2010
Treatment for: Diabetes Mellitus Type II
Victoza (liraglutide) 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 mellitus.
Company: Acorda Therapeutics, Inc.
Date of Approval: January 22, 2010
Treatment for: Multiple Sclerosis
Ampyra (dalfampridine) is an oral potassium channel blocker indicated to improve walking ability in people with multiple sclerosis.
- FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis - January 22, 2010
- Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010 - October 22, 2009
- Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR - October 14, 2009
- Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS - August 25, 2009
- Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug Application for Filing - May 6, 2009
- Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis - April 23, 2009
- Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA - March 31, 2009
- Acorda Therapeutics Submits NDA for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis - February 2, 2009
Company: Genentech USA, Inc.
Date of Approval: January 8, 2010
Treatment for: Rheumatoid Arthritis
Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis in adults.
- FDA Approves Actemra for the Treatment of Moderately to Severely Active Rheumatoid Arthritis - January 11, 2010
- Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab) - December 4, 2008
- FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application - September 18, 2008
- FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis - July 29, 2008
- Roche Submits Application for FDA Approval of Actemra for the Treatment of Rheumatoid Arthritis - November 21, 2007
Company: Lilly
Date of Approval: December 11, 2009
Treatment for: Schizophrenia
Zyprexa Relprevv (olanzapine) is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia.
- FDA Approves Lilly's Zyprexa Relprevv for Treatment of Schizophrenia in Adults - December 14, 2009
Company: Octapharma USA
Date of Approval: December 4, 2009
Treatment for: von Willebrand's Disease
Wilate is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD).
Company: Dyax Corp.
Date of Approval: December 1, 2009
Treatment for: Angioedema
Kalbitor (ecallantide) is plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.
- Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older - December 2, 2009
- Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema - June 8, 2009
- Dyax Receives Complete Response Letter from FDA for DX-88 in Acute Attacks of Hereditary Angioedema - March 27, 2009
- FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema - February 5, 2009
- Dyax Announces FDA Advisory Committee to Review DX-88 for Hereditary Angioedema - January 13, 2009
- FDA Accepts Filing and Grants Priority Review for DX-88 for Hereditary Angioedema - November 21, 2008
- Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema - September 24, 2008
Company: Merck & Co. and Santarus Inc.
Date of Approval: December 1, 2009
Treatment for: Heartburn
Zegerid OTC (omeprazole and sodium bicarbonate) is an over-the-counter version of the prescription heartburn drug Zegerid.
- FDA Approves OTC Version Of Heartburn Drug Zegerid - December 2, 2009
Company: Novartis Vaccines and Diagnostics, Inc.
Date of Approval: November 27, 2009
Treatment for: Influenza Prophylaxis
Agriflu (influenza virus vaccine, inactivated) is a vaccine indicated for the active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
- FDA Approves Agriflu Seasonal Influenza Vaccine - November 30, 2009
Company: NeurogesX, Inc.
Date of Approval: November 16, 2009
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
Company: Xanodyne Pharmaceuticals, Inc.
Date of Approval: November 13, 2009
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
Company: Gloucester Pharmaceuticals
Date of Approval: November 5, 2009
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
Company: Nuvo Research Inc.
Date of Approval: November 4, 2009
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
Company: GlaxoSmithKline
Date of Approval: October 26, 2009
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
Company: GlaxoSmithKline
Date of Approval: October 19, 2009
Treatment for: Renal Cell Carcinoma
Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Date of Approval: October 16, 2009
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
Company: GlaxoSmithKline
Date of Approval: October 16, 2009
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
Company: CSL Behring
Date of Approval: October 9, 2009
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
Company: Centocor Ortho Biotech Inc.
Date of Approval: September 25, 2009
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
FDA Drug Approvals Archive
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