Cipla Gets Tentative USFDA Approval
Major Indian pharma firm Cipla has notified that it has secured tentative approval from the United States Food and Drug Administration (USFDA) for its tenofovir disoproxil fumarate tablets.
In a disclosure to the Bombay Stock Exchange, the company said that Tenofovir disoproxil fumarate tablets are indicated for use in combination with other antiretroviral agents.
The drugs are prescribed for the treatment of HIV-1 infection in adults.
The company has received tentative approval to sell the drug in tablet form in dosages of 300 milligram under the President's Emergency Plan for AIDS Relief program.
It can be recalled that Tenofovir disoproxil fumarate tablets are the generic version of Gilead Sciences Inc.'s (GILD) truvada.
The Indian company is known for producing low-cost anti-AIDS drugs for HIV-positive patients in developing countries.
Moreover, Cipla makes drugs to treat cardiovascular disease, arthritis, diabetes, weight control, depression and many other health conditions. The products produced by the company are distributed in nearly 200 countries of the world.
May 14, 2009