Latest Generic Drug 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.
First-Time Generic Approvals June 2015
- Zolpidem Tartrate Sublingual Tablets 1.75 mg and 3.5 mg
Approved: June 3, 2015 - Novel Laboratories,Inc.
Generic for: Intermezzo
- Linezolid for Oral Suspension 100 mg/5 mL
Approved: June 3, 2015 - Roxane Laboratories, Inc.
Generic for: Zyvox for Oral Suspension
- Eptifibatide Injection 75 mg/100 mL
Approved: June 5, 2015 - Teva Pharmaceuticals USA Inc.
Generic for: Integrilin
- Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%
Approved: June 12, 2015 - Actavis Mid Atlantic LLC
Generic for: Ziana
- Gemifloxacin Mesylate Tablets 320 mg (base)
Approved: June 15, 2015 - Orchid Healthcare
Generic for: Factive
- Clindamycin Phosphate and Benzyl Peroxide Gel 1.2%/2.5%
Approved: June 19, 2015 - Actavis Laboratories, Inc.
Generic for: Acanya
- Ezetimibe Tablets 10 mg
Approved: June 26, 2015 - Glenmark Pharmaceuticals, Ltd.
Generic for: Zetia
- Desvenlafaxine Succinate Extended-Release Tablets 50 mg and 100 mg
Approved: June 29, 2015 - Alembic Pharmaceuticals Ltd.; Lupin Pharmaceuticals Inc.; Sandoz Inc.; Mylan Pharmaceuticals Inc.
Generic for: Pristiq