Strides Pharma Science Ltd on Thursday said its wholly-owned subsidiary Strides Pharma Global Pte Ltd, Singapore, has received tentative approval from the US health regulator for generic Dolutegravir tablets used in the treatment of HIV.
The approval granted by the US Food & Drug Administration (USFDA) is for Dolutegravir tablets of strength 50mg, Strides said in a statement.
The Abbreviated New Drug Application (ANDA) is tentatively approved under USFDA's expedited review provision for the President's Emergency Plan for AIDS Relief, thereby qualifying the company to participate in global donor-funded programmes that procure this lifesaving medicine, it said.
The medicine is supplied in 126 countries, it added.
"As of full year 2022, donor procurement for Dolutegravir 50mg tablets is estimated at a value of USD 35 million. This product further strengthens the available offerings in HIV treatment from Strides," the company said.
The approval adds to a list of products that Strides has approved under the PEPFAR pathway, taking the total to 13 products, it added.
The products will be manufactured at the company's facility in Bengaluru, Strides said, adding that the conversion of this tentative approval to a full approval is expected upon expiry of the constraining patents.
The Dolutegravir 50mg tablet has a USD 1.35 billion market opportunity in the US, Strides said, citing IQVIA data.
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First Published: Sep 14 2023 | 8:59 PM IST