Matrix Labs' Videx EC generic approved by FDA

PITTSBURGH A subsidiary of Mylan has won approval from the Food and Drug Administration to market a generic HIV drug under the President’s Emergency Plan for AIDS Relief, Mylan said Monday.

The generic drug maker said subsidiary Matrix Labs won approval for didanosine delayed-release capsules in the 125-mg, 200-mg, 250-mg and 400-mg strengths. Mylan said it expected to begin selling the drug in the United States soon and would also sell it in a number of developing countries.

The capsules are a generic version of Bristol-Myers Squibb’s Videx EC, which had sales of around $29 million in 2009, according to IMS Health.