Category: Approval/Launch Region: Asia · India Company: Lupin Ltd

Lupin gets US FDA tentative approval for dolutegravir tablets for oral suspension

Lupin gets US FDA tentative approval for dolutegravir tablets for oral suspension
Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), dolutegravir tablets for oral suspension, 5 mg, to market a generic equivalent of Tivicay PD tablets for oral suspension, 5 mg of ViiV Healthcare Company. This product will be manufactured at Lupin

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