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Drug firm Strides Arcolab today said it has received tentative approval from the US health regulator for anti-AIDS combination drug.
The company has received the approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Tenofovir Disoproxil Fumarate and Emtricitabine tablets in the strengths of 300 mg and 200 mg.
“The company is one among the six generics company to have received the US FDA approval. This ANDA has been reviewed under the expedited provisions of the President’s Emergency Plan for AIDS relief (PEPFAR),” it added.
The company supplies ARV products to global procurement agencies and this approval adds to the overall baskets of medicines available.
The drug is generic equivalent to Gilead Sciences Inc’s Truvada tablets and is indicated in combination with other anti-retroviral agents for treatment of HIV-1 infections in adults.
The company has 14 manufacturing facilities across six countries with presence in more than 75 countries in developed and emerging markets.
Strides Arcolab scrip closed at Rs 622.45 on the BSE, up 5.73 per cent over its previous close.
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