AEGiS-Reuters: Barr says FDA approves AIDS drug generic version

Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.

Barr says FDA approves AIDS drug generic version

Reuters NewMedia - December 3, 2004

NEW YORK (Reuters) - Barr Pharmaceuticals Inc. said on Friday the U.S. Food and Drug Administration approved the company's generic version of Videx EC, an AIDS treatment marketed by Bristol-Myers Squibb.

The FDA granted an expedited review of Barr's application to make a copycat version of the drug under the president's emergency plan for AIDS relief, the company said.

Barr said it plans to launch its generic product immediately.

Barr, based in Woodcliff Lake, New Jersey, filed in May 2004 an Abbreviated New Drug Application (ANDA) for didanosine delayed-release, the name of Videx EC's compound, in capsules of 200 mg, 250 mg and 400 mg.

Bristol-Myers Squibb and the National Institutes of Health, which owned the patent, did not challenge Barr's filing within a 45-day period after notification of the ANDA filing.

Videx EC in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infections in adults and has current annual sales of about $126 million, Barr said, citing sales data from health-care information provider IMS Health for the 12 months ended September 2004.

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