Caraco Pharmaceutical Laboratories, Ltd., announced 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, 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.