Caraco given approval to market generic Ultracet by FDA

New York, Dec. 19 - Caraco Pharmaceutical Laboratories, Ltd. said the Food and Drug Administration granted final approval for its Abbreviated New Drug Application for tramadol hydrochloride with acetaminophen tablets.

The drug is the generic equivalent of Ortho-McNeil Pharmaceutical Inc.'s Ultracet, which is indicated for the short-term - five days or less - management of acute pain.

Caraco said it plans to market the new treatment immediately, adding that it now has 19 different products at 41 strengths approved.

Caraco has been in a legal dispute with Ortho-McNeil over the generic version of Ultracet and its ANDA to the FDA included a certification challenging Ortho-McNeil's patent. On Oct. 19 Caraco was granted a motion for summary judgment. Ortho-McNeil had asked the court to direct the FDA not to approve the application any earlier than the Sept. 6, 2011 expiration of the patent.

Caraco Pharmaceutical is a Detroit-based maker of generic and private-label prescription pharmaceuticals.

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