Aurobindo Pharma Ltd has received US FDA tentative approval for didanosine oral suspension (paediatric 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, a company press release stated.
The 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 US FDA (inclusive of tentative approvals) and 17 of them are ARV's.
It is indicated for use in pediatric patients with human immunodeficiency virus (HIV).
Didanosine is active against the 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.