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Caraco Pharmaceutical Laboratories, Ltd. announced today that the FDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Glipizide/Metformin Hydrochloride Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg (Glipizide/Metformin HCl)
DETROIT, MI, USA | January 14, 2008 | Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Glipizide/Metformin Hydrochloride Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg (Glipizide/Metformin HCl).
Glipizide/Metformin HCl is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. It is also indicated as second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes. Our generic Glipizide/Metformin HCl is the bioequivalent to Metaglip(R), a registered trademark of Bristol-Myers Squibb Company. According to IMS Data, for the twelve months ended September 2007, Glipizide/Metformin HCl generic and brand products (Metaglip(R)) combined had annual sales of approximately $25 million.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to gain this approval from the FDA. Our focus continues to be working towards expanding our product line effectively, including products that are already available generically in the market that potentially can add measurable value."
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.
Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or cheaper products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward- looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.
SOURCE: Caraco Pharmaceutical Laboratories, Ltd. |
