USFDA gives tentative approval to Alembic Pharma’s acalabrutinib capsules, 100 mg EP News Bureau Jan 19, 2023 The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, calquence capsules, 100 mg, of…
USFDA gives tentative approval to Lupin’s Dolutegravir and Rilpivirine tablets EP News Bureau Jan 17, 2023 The tablets are used to treat HIV infection
USFDA gives tentative approval to Zydus’s Levomilnacipran extended-release capsules EP News Bureau Jan 16, 2023 The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad