Aurobindo's HIV drug, Ranbaxy's epillepsy drug get USFDA nod
01 Apr 2009
Indian pharma majors Aurobindo Pharma and Ranbaxy-Daiichi has received tentative approval for anti-retrovial and epillepsy drugs of the respective companies.
An Aurobindo release said the company's HIV Emtricitabine/Tenofovir Disoproxil Fumarate tablets, 200mg/300mg received tentative approval from the US Food and Drug Administration (USFDA).
Emtricitabine/Tenofovir Disoproxil Fumarate tablet is the generic equivalent of Gilead Sciences Truvada tablets and falls under the anti-retroviral (ARV) segment, the release said.
It is indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection in adults. This ANDA was reviewed under the expedited provisions of the President's Emergency Plan for AIDS relief (PEPFAR), it added.
Aurobindo now has a total of 95 ANDA approvals (66 Final approvals and 25 tentative approvals) from USFDA.
Ranbaxy-Daiichi, meanwhile, said it has received US regulatory approval for Topiramate tablets, used in the treatment of epilepsy.
The application for approval was submitted by Ranbaxy from Ohm Laboratories' manufacturing facility in New Jersey, the company said in a statement. Ohm Laboratories is a wholly-owned subsidiary of Ranbaxy Laboratories Ltd.
The approvals are related to abbreviated new drug application (ANDA) for manufacturing and marketing of Topiramate tablets with strengths of 25 mg 100 mg and 200 mg.
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