New Drug Approvals Archive
New Drug Approvals: June 2008
| June 5 | Reclast (zoledronic acid)
New Indication Approved: June 3, 2008 FDA broadens US indication for once-yearly Reclast as only osteoporosis treatment approved for prevention of fractures after a hip fracture |
| June 16 | Requip (ropinirole)
New Dosage Form Approved: July 1, 2008 U.S. FDA Approves Requip XL, the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease |
| June 16 | Cymbalta (duloxetine)
New Indication Approved: June 13, 2008 FDA Approves Cymbalta for the Management of Fibromyalgia |
| June 16 | Trivaris (triamcinolone acetonide) Intravitreal Injection Date of Approval: June 16, 2008 Company: Allergan, Inc. Treatment for: Ocular Inflammatory Conditions Trivaris (triamcinolone acetonide) is a glucocorticoid corticosteroid delivered via intravitreal injection for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Allergan Receives U.S. Food and Drug Administration Approval for Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL |
| June 20 | Avodart (dutasteride)
New Indication Approved: June 19, 2008 FDA Approves GlaxoSmithKline's Avodart in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate |
| June 20 | Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine) Date of Approval: June 20, 2008 Company: Sanofi pasteur Treatment for: Pertussis Prophylaxis, Tetanus Prophylaxis, Diphtheria Prophylaxis, Poliomyelitis Prophylaxis, Haemophilus influenzae Prophylaxis Pentacel is a combination vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age. U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine, Pentacel |
| June 23 | Velcade (bortezomib)
New Indication Approved: June 20, 2008 FDA Approves Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma |
| June 23 | PrandiMet (repaglinide and metformin) Tablets Date of Approval: June 23, 2008 Company: Sciele Pharma, Inc. and Novo Nordisk Inc. Treatment for: Diabetes Mellitus Type II PrandiMet (repaglinide and metformin HCl) is a fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin) and insulin sensitizer, metformin, indicated for the treatment of type 2 diabetes. FDA Approves PrandiMet, a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes |
| June 23 | Durezol (difluprednate) Ophthalmic Emulsion Date of Approval: June 23, 2008 Company: Sirion Therapeutics, Inc. Treatment for: Postoperative Ocular Inflammation Durezol (difluprednate ophthalmic emulsion) is a topical steroid for the treatment of postoperative ocular inflammation and pain. Sirion Therapeutics Announces FDA Approval of Durezol for Treatment of Postoperative Ocular Inflammation and Pain |
| June 24 | Aptivus (tipranavir)
New Dosage Form Approved: June 23, 2008 New Aptivus (tipranavir) Oral Solution Approved for Treatment-Experienced Pediatric and Adolescent HIV Patients |
| June 24 | Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) Date of Approval: June 24, 2008 Company: GlaxoSmithKline Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Poliomyelitis Prophylaxis, Pertussis Prophylaxis Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine] is a combination vaccine for protection against diphtheria, tetanus, pertussis and polio diseases in children. FDA Approves Kinrix - New Combination Vaccine for Children |
| June 27 | Concerta (methylphenidate)
Patient Population Altered: June 27, 2008 FDA Approves Concerta (methylphenidate HCl) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults |
| June 27 | Metvixia (methyl aminolevulinate hydrochloride)
New Formulation Approved: June 26, 2008 Photocure Receives FDA Approval for Metvixia/Aktilite Photodynamic Therapy |
| June 27 | Evolence (dermal filler) Date of Approval: June 27, 2008 Company: OrthoNeutrogena Treatment for: Facial Wrinkles Evolence is a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. FDA Approves Evolence, a New Generation Collagen-Based Facial Filler |
| June 10 | Evolence (dermal filler)
Labeling Revision Approved: June 8, 2009 Treatment for: Facial Wrinkles FDA Approves 12-Month Labeling Update for Evolence Collagen-Based Facial Filler |
New Drug Approvals Archive
2009: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Jan | Feb | Jul | Aug | Oct | Nov | Dec
