India's Lupin gets two generics approvals from FDA

4 July 2023

Mumbai, India-based generic drugmaker Lupin Limited (BSE: 500257) saw US regulatory approval for two of its copy medicines in the space of two days.

Today, Lupin announced that it has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) on dolutegravir tablets for oral suspension, 5mg, to market a generic equivalent of HIV drug Tivicay PD tablets for oral suspension, 5mg of ViiV Healthcare, which is majority owned by UK pharma major GSK (LSE: GSK).

This product will be manufactured at Lupin’s Nagpur facility in India.

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