Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of...( DETROIT June 30 /- Caraco Pharmac...),Health
DETROIT, June 30 /PRNewswire-FirstCall/ -- 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 Applications (ANDAs) for Amitriptyline Hydrochloride USP Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.
Amitriptyline Hydrochloride is an antidepressant. Its use is indicated to treat symptoms of depression. According to IMS Data, for the twelve months ended March, 2008, Amitriptyline Hydrochloride USP Tablets had annual generic sales of approximately $16 million. It is marketed under the brand name of Elavil(R), a registered trademark of AstraZeneca.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to gain these approvals from the FDA. Our focus continues to be working towards expanding our product portfolio effectively, including products that are already available generically in the market that potentially can offer additional 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
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