US regulator's nod for Strides arm's drug to treat HIV
(4 months ago)
Bengaluru, Jan 31 : Strides Pharma Global Pte Ltd, an arm of Strides Shasun, has received approval of the US Food and Drug Administration (USFDA) for its tablets to treat the HIV-1 infection, said the drug major on Wednesday.
"We have received approval of the US regulator (FDA) for the production of 300mg Tenofovir Disoproxil Fumarate tablets for treating HIV-1 infection in adults with a combination of other antiretroviral agents," the city-based firm said in a statement here.
The drug is a generic version of Gileads's Viread tablet, for which the patent expired on January 25.
"We already have the US regulatory approval for supplying the tablets under the US Emergency Plan for AIDS Relief programme," noted the statement.
The company is among those launching the drug in the US market soon after the patent's expiry.
According to the Information Management Service (IMS) data, the US market for the company's tablet drug is about $750 million.
"The drug will be manufactured at our oral dosage facility in the city and marketed by the parent company (Strides) in the US market soon.
The tablet is recommended to also treat chronic hepatitis B in adults.
The integrated firm has three verticals - regulated, emerging markets and active pharmaceutical ingredients.
The global firm has nine manufacturing facilities the world over, including 7 regulatory approved in the US and two in the emerging markets.