| May 2 |
FDA Approves Oscient Pharmaceuticals' Factive Tablets for Five-Day
Treatment of Community-Acquired Pneumonia |
|
| May 2 |
FDA Approves Fragmin as First Low-Molecular-Weight Heparin for
Extended Treatment to Reduce the Recurrence of Blood Clots in
Patients with Cancer |
|
| May 3 |
Minrad International, Inc. Announces FDA Approval of Sojourn
Sevoflurane |
|
| May 3 |
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 4 |
Date of Approval: May 3, 2007 Company: Indevus Pharmaceuticals, Inc. Treatment for Central 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 |
FDA Approves New Dosage Strength of Fosamax Plus D (alendronate
sodium/cholecalciferol), Increasing Vitamin D Intake for Patients
with Osteoporosis |
|
| May 9 |
Baxter Receives Approval to Process Aralast NP |
|
| May 9 |
IMPAX Receives Final FDA Approval for Generic Ditropan XL 5 mg and
10 mg |
|
| May 10 |
Neupro (rotigotine) Transdermal System Date of Approval: May 9, 2007 Company: Schwarz Pharma Treatment for Parkinson's Disease Neupro 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 |
Barr Receives Tentative Approval for a Generic Version of Razadyne
Tablets, 4mg, 8mg and 12mg |
|
| May 11 |
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 15 |
Omrix Biopharmaceuticals Receives Food and Drug Administration
Approval for Liquid Fibrin Sealant, Evicel, For Use in Vascular
Surgery |
|
| May 18 |
New Dosage Form Approved: May 17, 2007
FDA Approves Astrazeneca's Once-Daily Seroquel XR Extended-Release
Tablets for the Treatment of Schizophrenia |
|
| May 18 |
FDA Approves Lovenox (Enoxaparin Sodium Injection) for the Most
Severe Type of Heart Attack |
|
| May 21 |
U.S. FDA Approves Velcade + Doxil Combination for Treatment of
Relapsed/Refractory Multiple Myeloma |
|
| May 21 |
Teva Provides Update on Generic Lotrel |
|
| May 21 |
Cervarix is Approved in Australia for Females 10-45 Years Old |
|
| May 23 |
Lybrel (levonorgestrel and ethinyl estradiol) Low Dose Continuous Regimen Date of Approval: May 22, 2007 Company: Wyeth Pharmaceuticals Inc. Treatment for Contraception Lybrel 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 23 |
FDA Approves Contraceptive for Continuous Use |
|
| May 24 |
FDA Approves Tindamax for Bacterial Vaginosis |
|
| May 29 |
Xyzal (levocetirizine dihydrochloride) Date of Approval: May 25, 2007 Company: UCB, Inc. and sanofi-aventis Treatment for Allergic Rhinitis, Allergic Urticaria Xyzal 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 29 |
QLT USA, Inc. files Aczone labeling supplement for removal of blood
screening requirement |
|
| May 30 |
Caraco Pharmaceutical Laboratories Ltd. Announces Tentative FDA
Approval for Generic Zyrtec |
|
| May 31 |
Date of Approval: May 30, 2007 Company: Wyeth Pharmaceuticals, Inc. Treatment for Advanced Renal Cell Carcinoma Torisel, 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 |
|
| May 31 |
FDA Approves Critical Therapeutics' Twice-Daily Zyflo CR (Zileuton)
Extended-Release Tablets for Asthma |
|
| May 31 |
FDA Approves New Drug for Advanced Kidney Cancer |
|
| May 31 |
Avanir Receives FDA Approval for New Formulation of Currently
Marketed Antipsychotic Drug FazaClo |
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