Par Pharmaceutical Receives Approval to Market Generic Ultracet

Par Pharmaceutical Companies' wholly owned subsidiary, Kali Laboratories has received final approval from the FDA for its abbreviated new drug application (ANDA) for tramadol HCl and acetaminophen tablets.

Kali has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a Paragraph IV certification for the product. Ortho-McNeil Pharmaceutical currently markets 37.5 mg tramadol HCl/325 mg acetaminophen tablets under the brand name Ultracet.

The product is indicated for the short-term (five days or less) management of acute pain and has annual U.S. sales of approximately $350 million.