Mylan Inc. said on Monday that its Indian arm Matrix Laboratories Limited has secured its first tentative approval from the U.S. Food and Drug Administration to market Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in two potencies 200 mg and 300 mg.

It should be noted that the tablets are the generic version of Gilead Science Inc.'s HIV drug Truvada Tablets.

The company said its version was granted tentative approval under the President's Emergency Plan for AIDS Relief.

Robert J. Coury, Mylan Vice Chairman and CEO, stated, “This product approval is yet another important step in providing access to a range of critical HIV medications to patients in developing countries. Mylan and Matrix continue to make a significant contribution to bringing down the cost of these vital treatments through the expansion of our high-quality anti-retroviral franchise.”

Truvada, a combination of two drugs, emtricitabine and tenofovir disoproxil fumarate, is a second-line anti-HIV drug in the family of nucleoside reverse transcriptase inhibitor.

It is used along with other medicinal drugs to put control over HIV infection. Patients often use second-line therapies if and when they develop resistance to initially prescribed treatments or experience clinical failures.

The annual sales of Truvada, Gilead's best-selling product, increased to $2.11 billion during the last year (2008).

In aftermarket trading, Mylan shares remained unchanged at $13.05.

Shares of Foster City, Calif.-based Gilead Sciences stood at $44.95, down 67 cents, after closing at $45.62.