The Hindu Business Line : Aurobindo gets FDA nod for AIDS drug

Aurobindo Pharma Ltd has announced that the United Sates Food and Drug Administration (USFDA) has granted tentative approval for the company's Didanosine Oral Suspension (paediatric powder) 10 mg/ml.

The drug is indicated for use in paediatric patients with HIV. Didanosine is active against the human immunodeficiency virus (HIV) that causes AIDS.

It is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which helps keep the AIDS virus from reproducing. The drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

In a press release here on Tuesday, the company said this product is the first generic version of the research product, Videx paediatric powder for Oral Suspension, 10-mg/ml, manufactured by Bristol Myers Squibb Pharmaceuticals.

Aurobindo Pharma 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, Aurobindo Pharma now has 32 products approved by USFDA (inclusive of tentative approvals) and 17 of them are anti-retrovirals (ARVs).

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