Alembic Pharma receives USFDA nod for Pregabalin capsules, Health News, ET HealthWorld

Mumbai: Alembic Pharmaceuticals Limited introduced that it has obtained PAS (Prior Approval Supplement) approval from the US Food Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) Pregabalin capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.The sANDA, submitted as “Prior Approval Supplement,” supplies for an alternate drug product manufacturing web site, Alembic Pharmaceuticals Limited, Formulation Division IV, Jarod, Gujarat, India for beforehand permitted ANDA from Panelav Facility (F-I). This is the primary product approval from Jarod facility which was inspected in Dec 2022.The permitted sANDA is therapeutically equal to the reference listed drug product (RLD), Lyrica Capsules, of Upjohn. Pregabalin capsules are indicated for neuropathic ache, postherpetic neuralgia, and different indications.These capsules have an estimated market dimension of US$ 244 million for twelve months ending Sep 2022 in accordance with IQVIA.

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