Aurobindo drug gets nod

Hyderabad: Aurobindo Pharma Ltd has announced that the United States Food and Drug Administration (USFDA) has granted tentative approval for Didanosine tablets (chewable) of strengths 100 mg, 150 mg and 200 mg.

In a press release here on Wednesday, the company said this is the first generic version approval of Didanosine chewable in the world given by USFDA. Didanosine is the version of VIDEX an anti-HIV medication manufactured by Bristol Myers Squibb.

The company said the product would now be available for consideration for purchase under the US President's Emergency Programme for AIDS Relief (PEPFAR). The company said it manufactures both active pharmaceutical ingredient (API) and formulation for this generic.

With this approval, the anti-retroviral (ARV) product portfolio of the company has increased to 17.

Didanosine is a NRTI class of drugs and a key component of the ARV regimens in various parts of the world. This molecule enjoys approximately $100-million of market share.