New Drug Approvals Archive
New Drug Approvals: May 2007
| May 2 | Perlane (dermal filler) Date of Approval: May 2, 2007 Company: Medicis Treatment for: Facial Wrinkles Perlane is a dermal filler for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds. Medicis Announces FDA Approval of Perlane |
| May 3 | Supprelin-LA (histrelin acetate) Subcutaneous Implant Date of Approval: May 3, 2007 Company: Indevus Pharmaceuticals, Inc. Treatment for: Precocious Puberty Supprelin-LA is a once-yearly implant of the gonadotropin releasing hormone (GnRH) analog histrelin, indicated for the treatment of central precocious puberty (CPP), the premature onset of puberty in children. Indevus Announces FDA Approval of Supprelin-LA |
| May 9 | Neupro (rotigotine) Transdermal System Date of Approval: May 9, 2007 Company: Schwarz Pharma Treatment for: Parkinson's Disease Neupro (rotigotine) is a non-ergolinic dopamine agonist transdermal system, administered once daily for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease. FDA Approves Schwarz Pharma's Neupro (Rotigotine Transdermal System) for the Treatment of Early-Stage Parkinson's Disease in USA |
| May 11 | Perforomist (formoterol fumarate) Inhalation Solution Date of Approval: May 11, 2007 Company: Dey, L.P. Treatment for: Chronic Obstructive Pulmonary Disease Perforomist is an inhalation solution formulation of the long-acting beta(2)-adrenergic agonist formoterol fumarate, indicated for the long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD). FDA Approves Dey, L.P.'s Perforomist (Formoterol Fumarate) Inhalation Solution for Maintenance Treatment of COPD |
| May 18 | Seroquel (quetiapine)
New Dosage Form Approved: May 17, 2007 FDA Approves Astrazeneca's Once-Daily Seroquel XR Extended-Release Tablets for the Treatment of Schizophrenia |
| May 22 | Lybrel (levonorgestrel and ethinyl estradiol) Low Dose Continuous Regimen Date of Approval: May 22, 2007 Company: Wyeth Pharmaceuticals Inc. Treatment for: Contraception Lybrel (levonorgestrel and ethinyl estradiol) is a low-dose combination contraceptive pill taken continuously (without a pill-free interval) and over time may eliminate scheduled menstrual periods. Lybrel is indicated for the prevention of pregnancy. FDA Approves Lybrel, First Low Dose Combination Oral Contraceptive Offering Women the Opportunity to Be Period-Free Over Time |
| May 25 | Xyzal (levocetirizine dihydrochloride) Date of Approval: May 25, 2007 Company: UCB, Inc. and sanofi-aventis Treatment for: Allergic Rhinitis, Allergic Urticaria Xyzal (levocetirizine) is an antihistamine for the relief of symptoms associated with allergic rhinitis and urticaria. FDA Approves Xyzal (Levocetirizine Dihydrochloride) Tablets for the Relief of Seasonal and Year Round Allergies, and Chronic Hives |
| May 30 | Torisel (temsirolimus) Injection Date of Approval: May 30, 2007 Company: Wyeth Pharmaceuticals, Inc. Treatment for: Renal Cell Carcinoma Torisel (temsirolimus), an inhibitor of mTOR kinase, is an antineoplastic agent indicated for the treatment of patients with advanced renal cell carcinoma. FDA Approves Torisel, a Targeted First-in-Class mTOR Inhibitor for the Treatment of Advanced Kidney Cancer |
| February 19 | Xyzal (levocetirizine dihydrochloride)
New Dosage Form Approved: January 28, 2008 FDA Approves Xyzal (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria |
| August 25 | Xyzal (levocetirizine dihydrochloride)
Patient Population Altered: August 21, 2009 FDA Approves Xyzal For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria |
New Drug Approvals Archive
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