Matrix Laboratories, a subsidiary of Mylan Inc, has received final approval from the US FDA under the President's Emergency Plan for AIDS Relief (PEPFAR) for its ANDA for didanosine delayed-release capsules, 125 mg, 200 mg, 250 mg and 400 mg, the generic version of Bristol Myers Squibb's HIV treatment Videx EC. This product, which the company expects to begin marketing in the US during the current quarter, will be sold under the Mylan Pharmaceuticals brand. The product will also be sold outside the US in a number of developing countries.

Didanosine delayed-release capsules had US sales of approximately US$ 29 million for the 12 months ending December 31, 2009, according to IMS Health.

Currently, Mylan has 140 ANDAs pending US FDA approval representing US$ 98.3 billion in annual brand sales. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing US$ 19.8 billion in annual brand sales, for the 12 months ending December 31, 2009, according to IMS Health.