Aurobindo receives US FDA nod for Didanosine tablets
New Delhi, July 12 (UNI) Aurobindo Pharma today announced that the US FDA has granted a tentative approval for Didanosine tablets of strengths 100mg, 150mg and 200mg.
This is the first generic version approval to Didanosine tablets in the world given by US FDA, a company statement said here.
The product will now be available for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
The company manufactures both active pharmaceutical ingredients (API) and formulation for this generic.
With this approval, the anti-retroviral (ARV) product portfolio of the company has increased to 17.
Didanosine helps prevent AIDS virus from reproducing and is used in combination with other anti-retroviral agents for the treatment of HIV-1 infection.
It is the version of VIDEX, an anti-HIV medication manufactured by Bristol Myers Squibb.
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