New Indications and Dosage Forms for 2008
See also: New Drug Approvals for 2008
January 2, 2008
January 3, 2008
January 8, 2008
January 15, 2008
January 22, 2008
January 23, 2008
February 4, 2008
February 19, 2008
February 22, 2008
- Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
February 25, 2008
February 28, 2008
February 29, 2008
March 3, 2008
April 23, 2008
May 8, 2008
May 9, 2008
- Abilify (aripiprazole) Receives Expanded Indications for Maintenance Treatment in Both Pediatric Patients (Aged 10-17) With Manic and Mixed Episodes of Bipolar I Disorder and Adolescents (Aged 13-17) With Schizophrenia
- U.S. Food and Drug Administration Approves Abilify (aripiprazole) for Add-On Treatment to Lithium or Valproate in the Acute Treatment of Adults With Manic and Mixed Episodes of Bipolar I Disorder With or Without Psychotic Features
May 12, 2008
- FDA Approves Taclonex Scalp - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis
May 13, 2008
May 14, 2008
June 5, 2008
June 16, 2008
- U.S. FDA Approves Requip XL, the First and Only Oral Once-DailyNon-Ergot Dopamine Agonist for Parkinson's Disease
- FDA Approves Cymbalta for the Management of Fibromyalgia
June 20, 2008
June 23, 2008
June 24, 2008
June 27, 2008
- FDA Approves Concerta (methylphenidate HCl) Extended-releaseTablets for Treatment of ADHD (Attention Deficit HyperactivityDisorder) in Adults
- Photocure Receives FDA Approval for Metvixia/Aktilite Photodynamic Therapy
July 1, 2008
August 1, 2008
August 4, 2008
August 11, 2008
August 21, 2008
August 25, 2008
August 26, 2008
September 3, 2008
September 15, 2008
- FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
- Keppra XR Approved in the U.S.
- FDA Grants Approval to Talecris Biotherapeutics for Gamunex as a Treatment for Neurological Disorder CIDP in the United States
September 23, 2008
September 24, 2008
September 29, 2008
October 2, 2008
October 10, 2008
- FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment
- FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US
October 22, 2008
- U.S. Food and Drug Administration (FDA) Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1
- FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
October 29, 2008
November 3, 2008
November 6, 2008
- Crestor Approved for Primary Dysbetalipoproteinemia
- FDA Approves Ranexa for First Line Anti Anginal Use
November 11, 2008
November 12, 2008
November 13, 2008
December 12, 2008
December 13, 2008
December 19, 2008
- Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application
- Cumberland Pharmaceuticals Reports FDA Approval for Updated Labeling of Acetadote