Aurobindo Pharma Ltd today said it has received tentative approval by USFDA for its anti-HIV drug, Didanosine chewable tablets of 100mg, 150mg and 200mg strengths.
This is the first generic version approval for Didanosine chewable in the world given by USFDA, Aurobindo Pharma informed the Bombay Stock Exchange.
The aforesaid product would now be available for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR), it added.
The company manufactures both Active Pharmaceutical Ingredients (API) and formulation for this generic version and with this approval, the antiretroviral (ARV) product portfolio of the company increased to 17.
Didanosine is a Nucleoside reverse transcriptase inhibitor (NRTI) class of drugs, and a key component of the ARV regimens in various parts of the world. This molecule enjoys approximately USD 100 mio of market share, it said.
The drug helps prevent AIDS virus from reproducing. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection. It is the version of VIDEX an anti-HIV medication manufactured by Bristol Myers Squibb.
The shares of the company was trading at Rs 608, up 2.16 per cent at the BSE.