(dailyRx)

Mylan Inc. has announced it has received the first tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg.

Emtricitabine and tenofovir disoproxil fumarate tablets are the generic
version of Gilead Sciences Inc.'s Truvada tablets. Truvada is a
second-line anti-HIV drug in the nucleoside reverse transcriptase
inhibitor (NRTI or "nuke") family. It is used in combination with other
medications to control HIV infection. Patients often use second-line
therapies if and when they develop resistance to initially prescribed
treatments or experience clinical failures.

Mylan's vice chairman and CEO Robert J. Coury said, "This product approval is yet another important step in providing access to a range of critical HIV medications to patients in developing countries."

Contact:
Jennifer Jurosco
724-514-1968