First-Time Generic Approvals: Metaglip, Zofran ODT, Floxin Otic

Yael Waknine

November 22, 2005

Editor's Note: According to the FDA Web site, on Nov. 29, 2005, the FDA's Center for Drug Evaluation and Research (CDER) rescinded the Nov. 18, 2005, approval of Kali Laboratories' ANDA 76-506 for ondansetron orally disintegrating tablets, 4 mg and 8 mg. The reference listed drug for this ANDA is Zofran (GlaxoSmithKline), which is used to treat nausea and vomiting. CDER took this action because the U.S. District Court for the District of New Jersey issued a decision finding that this ANDA infringes a patent of GlaxoSmithKline that has not yet expired. Pediatric exclusivity attaches to this patent, and is not due to expire until Dec. 24, 2006. Kali has informed CDER that Kali has appealed this court decision.

Nov. 22, 2005 — The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of glipizide/metformin HCl 2.5-mg/250-mg, 2.5-mg/500-mg, and 5-mg/500-mg tablets for first- and second-line use to improve glycemic control in patients with type 2 diabetes mellitus; ondansetron 4- and 8-mg orally disintegrating tablets for the prophylaxis of nausea and vomiting; and ofloxacin 0.3% otic solution for the treatment of ear infections caused by susceptible microorganisms.


Generic Glipizide Plus Metformin HCl Tablets (Metaglip) for Type 2 Diabetes

On Oct. 27, the FDA approved first-time generic formulations of glipizide plus metformin HCl 2.5-mg/250-mg, 2.5-mg/500-mg, and 5-mg/500mg tablets (made by CorePharma, LLC; brand name Metaglip, made by Bristol-Myers Squibb Co.). In addition, generic formulations made by Teva Pharmaceuticals USA, Inc. were approved on Oct. 28.

Glipizide/metformin tablets are indicated for first-line use (as an adjunct to diet and exercise) to improve glycemic control in patients with type 2 diabetes mellitus. They are also indicated for second-line use in patients whose hypoglycemia is inadequately controlled by initial treatment with a sulfonylurea or metformin.


Generic Ondansetron Orally Disintegrating Tablets (Zofran ODT) for Antiemetic Use

On Nov. 18, the FDA approved first-time generic formulations of ondansetron 4- and 8-mg orally disintegrating tablets (made by Kali Laboratories, Inc., Bedford Laboratories, Mayne Pharma USA, Inc., and Taro Pharmaceuticals USA, Inc.; brand name Zofran ODT, made by GlaxoSmithKline).

Ondansetron is indicated for the prophylaxis of nausea and vomiting associated with emetogenic cancer chemotherapy and certain radiotherapies. It is also indicated for the prevention of postoperative nausea and/or vomiting.


Generic Ofloxacin Otic Solution (Floxin Otic) for the Treatment of Ear Infections

On Nov. 18, the FDA approved a first-time generic formulation of ofloxacin 0.3% otic solution (made by Hi Tech Pharmacal Company, Inc., Apotex, Inc., and Bausch & Lomb, Inc.; brand name Floxin Otic, made by Daiichi Pharmaceutical Corp.).

Ofloxacin otic solution is indicated for the treatment of otitis externa, chronic suppurative otitis media, and acute otitis media caused by susceptible microorganisms.

Reviewed by Gary D. Vogin, MD

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