FDA Approves Barr’s Generic Version of BMS’ Antiretroviral Drug Videx, Barr Says

Officials from Woodcliff, N.J.-based Barr Laboratories on Friday announced that FDA has approved the company's generic version of the antiretroviral drug didanosine, sold by Bristol-Myers Squibb under the brand name Videx EC, Reuters reports. Didanosine is used in combination with other antiretroviral drugs for the treatment of HIV-1 infections. Barr in May filed an Abbreviated New Drug Application to manufacture, market and sell didanosine in capsules of 200 mg, 250 mg and 400 mg. FDA granted an expedited review of Barr's application under the President's Emergency Plan for AIDS Relief and neither BMS nor NIH -- which owns the patent on didanosine -- challenged Barr's filing within 45 days of notification. Barr plans to launch its generic version of didanosine immediately, according to Reuters (Reuters, 12/3). Upon the drug's launch, Barr will be entitled to 180 days of generic exclusivity, according to a Barr release. Barr Chair and CEO Bruce Downey said, "We applaud the FDA for expediting the review for this important medicine in the fight against AIDS, which allows us to bring a more cost effective version of this therapy to patients who need it sooner than would have otherwise been possible" (Barr release, 12/3).