Aurobindo receives US FDA approval for Didanosine Oral Suspension

Aurobindo Pharma Ltd has announced that the US FDA has granted tentative approval for Company’s Didanosine Oral Suspension (Pediatric Powder) 10 mg/ml.

This product is the first generic version of the research product, Videx Pediatric Powder for Oral Suspension, 10-mg/ml, manufactured by Bristol Myers Squibb Pharmaceuticals.

The aforesaid product will now be available for consideration for purchase under the PEPFAR. The Company manufactures both API and formulation for this generic. With this approval the Company has 32 products approved by USFDA (inclusive of tentative approvals) and 17 of them are ARV’s.

It is indicated for use in pediatric 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. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Source : Equity Bulls

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