Approval of Phentermine HCL
Food and Drug Administration (FDA) in 1959 apporved Phentermine as an appetite suppressant for the short-term treatment of obesity. By 1970s, Phentermine Hydrochloride was also available in the United States market.
Caraco Pharmaceutical Laboratories’s, abbreviated as, New Drug Application (ANDA) got the approval for Phentermine Hydrochloride Tablets USP, 37.5 mg (Phentermine HCl) in September 1997.
Phentermine HCl is indicated only as short-term monotherapy for the management of exogenous obesity. Our generic Phentermine HCl is the bioequivalent to Adipex-P(R), a registered trademark of TEVA Pharmaceuticals USA, Inc. According to IMS Data, for the twelve months ended June 2007, Phentermine HCl generic and brand products (Adipex-P(R)) combined had annual sales of approximately $34 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. We plan to market this product to the generic pharmaceutical market immediately. This will bring our total product selection to 36 different products represented by 74 various strengths.”
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.
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