New Drug Approvals

New Drug Approvals

The following drugs have recently been approved by the FDA.
Lumizyme (alglucosidase alfa)
Date of Approval: May 24, 2010
Treatment for: Pompe disease
Lumizyme Drug Information | Press Release

Zymaxid (gatifloxacin) Ophthalmic Solution
Date of Approval: May 18, 2010
Treatment for: Bacterial Conjunctivitis
Zymaxid Drug Information | Press Release

Sprix (ketorolac tromethamine) Nasal Spray
Date of Approval: May 14, 2010
Treatment for: Pain
Sprix Drug Information | Press Release

Natazia (dienogest and estradiol valerate)
Date of Approval: May 6, 2010
Treatment for: Contraception
Natazia Drug Information | Press Release

Vimovo (naproxen and esomeprazole magnesium)
Date of Approval: April 30, 2010
Treatment for: Osteoarthritis, Rheumatoid Arthritis, Ankylosing
Spondylitis, NSAID-Induced Ulcer Prophylaxis
Vimovo Drug Information | Press Release

First-Time Generic Approvals
First Time Generics are those drug products that have never been
approved before as generic drug products and are new generic products
to the marketplace.
Losartan Potassium and Hydrochlorothiazide Tablets
50 mg/12.5 mg and 100 mg/25 mg
Approved: April 6, 2010 Teva Pharmaceuticals USA
Generic for: Hyzaar Tablets

Losartan Potassium and Hydrochlorothiazide Tablets
100 mg/12.5 mg
Approved: April 6, 2010 Roxane Laboratories, Inc.; Mylan
Pharmaceuticals, Inc.; Torrent Pharmaceuticals, Ltd.; Teva
Pharmaceuticals USA
Generic for: Hyzaar Tablets

Losartan Potassium Tablets
USP, 25 mg, 50 mg and 100 mg
Approved: April 6, 2010 Teva Pharmaceuticals USA
Generic for: Cozaar Tablets

Memantine Hydrochloride Tablets
5 mg and 10 mg
Approved: April 14, 2010 Dr. Reddy's Laboratories Limited
Generic for: Namenda Tablets

Imipramine Pamoate Capsules
75 mg, 100 mg, 125 mg and 150 mg
Approved: April 14, 2010 Roxane Laboratories, Inc.; Lupin Limited
Generic for: Tofranil-PM Capsules

Amoxicillin & Clavulanate Potassium Extended-Release Tablets
1000 mg/62.5 mg (base)
Approved: April 21, 2010 Sandoz Inc.
Generic for: Augmentin XR Tablets

Voriconazole Tablets
50 mg and 200 mg
Approved: April 22, 2010 Matrix Laboratories Limited
Generic for: Vfend Tablets