New Drug Approvals Archive
New Drug Approvals: October 2008
| October 2 | Reyataz (atazanavir sulfate)
Patient Population Altered: September 30, 2008 U.S. Food & Drug Administration Approved the use of Reyataz (atazanavir sulfate) Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients |
| October 8 | Akten (lidocaine hydrochloride) Ophthalmic Gel Date of Approval: October 7, 2008 Company: Akorn, Inc. Treatment for Ocular Anesthesia Akten (lidocaine hydrochloride) Ophthalmic Gel is a topical, ocular anesthetic formulation for use in ocular procedures that require a topical anesthetic agent. Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5% |
| October 9 | Rapaflo (silodosin) Capsules Date of Approval: October 8, 2008 Company: Watson Pharmaceuticals, Inc. Treatment for Benign Prostatic Hyperplasia Rapaflo (silodosin) is an alpha(1)- adrenoreceptor antagonist for the treatment of the signs and symptoms associated with benign prostatic hyperplasia (BPH), or enlarged prostate. Watson Receives US FDA Approval for Rapaflo (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH) |
| October 10 | Risperdal (risperidone)
New Dosage Regimen: October 10, 2008 FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment |
| October 10 | Seroquel (quetiapine)
New Indication Approved: October 8, 2008 FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US |
| October 10 | FDA Approves Bayer HealthCare's Kogenate FS Treatment for Routine Prophylaxis in Children with Hemophilia A |
| October 13 | Cinryze (C1 Esterase Inhibitor (Human)) Date of Approval: October 10, 2008 Company: Lev Pharmaceuticals, Inc. Treatment for Angioedema Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE). Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks |
| October 17 | Astepro (azelastine) Nasal Spray Date of Approval: October 15, 2008 Company: Meda AB Treatment for Allergic Rhinitis Astepro (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis. FDA Approves Astepro |
| October 21 | Acanya (benzoyl peroxide and clindamycin phosphate) Topical Gel Date of Approval: October 21, 2008 Company: Dow Pharmaceutical Sciences, Inc. Treatment for Acne Acanya (benzoyl peroxide and clindamycin phosphate) is a topical antibacterial and antibiotic combination for the treatment of acne. FDA Approves Acanya |
| October 22 | Prezista (darunavir)
Patient Population Altered: October 21, 2008 U.S. Food and Drug Administration (FDA) Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1 |
| October 22 | Vaprisol (conivaptan hydrochloride)
New Formulation Approved: October 8, 2008 FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia |
| October 27 | LoSeasonique (ethinyl estradiol and levonorgestrel) Extended-Cycle Oral Contraceptive Tablets Date of Approval: October 24, 2008 Company: Duramed Pharmaceuticals, Inc. Treatment for Contraception LoSeasonique is a lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy. FDA Approves Duramed's LoSeasonique Oral Contraceptive |
| October 29 | Novartis Secures Two FDA Approvals for Parkinson's Drug Stalevo |
| October 29 | Apidra (insulin glulisine)
Patient Population Altered: October 24, 2008 FDA Approves Rapid-Acting Insulin Apidra for Treatment of Children with Diabetes |
| October 29 | Vimpat (lacosamide) Date of Approval: October 28, 2008 Company: UCB Treatment for Seizures Vimpat (lacosamide) is an anti-convulsant drug for the treatment of partial onset seizures in adults with epilepsy. UCB's Vimpat Approved By U.S. FDA As Adjunctive Therapy for Partial Onset Seizures in Adults |
| October 30 | FDA Approves New Indication for Hospira's Precedex (dexmedetomidine HCl) Injection |
| October 31 | Toviaz (fesoterodine fumarate) Extended Release Tablets Date of Approval: October 31, 2008 Company: Pfizer Inc. Treatment for Urinary Frequency Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Pfizer's Toviaz (fesoterodine fumarate) Receives FDA Approval for the Treatment of Overactive Bladder |
New Drug Approvals Archive
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