The US Food and Drug Administration have granted final approval to Caraco Pharmaceutical Laboratories’ abbreviated new drug application (ANDA) for tramadol hydrochloride with acetaminophen tablets.

Caraco's tramadol hydrochloride (HCl) with acetaminophen tablets is the generic equivalent of Ortho-McNeil Pharmaceutical Inc. brand product, Ultracet, which is indicated for the short-term (five days or less) management of acute pain, informs a company release.

"We are extremely pleased on receiving this approval and plan to launch this product to the market immediately. This approval brings our total product portfolio to 19 different products represented by 41 strengths," said Daniel H. Movens, chief executive officer, Caraco.

On September 22, 2004, Ortho-McNeil Pharmaceutical Inc filed a complaint in the United States District Court for the Eastern District of Michigan alleging that the company's filing of an ANDA seeking approval to market its generic version of Ortho-McNeil's Ultracet drug product infringed Ortho-McNeil's patent, which expires on September 6, 2011. Ortho- McNeil sought an order from the court which, among other things, directed the FDA not to approve Caraco's ANDA any earlier than the claimed expiration date. The ANDA filed by Caraco contained a Paragraph IV Certification challenging the Ortho-McNeil patent.

Caraco Pharmaceutical Laboratories Ltd., develops, manufactures and distributes generic and private-label prescription pharmaceuticals to the nation's wholesalers, distributors, drugstore chains and managed care providers.