Last Updated on October 2, 2024 by The Health Master
The United States Food and Drug Administration (USFDA) has given Prior Approval Supplement (PAS) approval to Alembic Pharma’s 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 ANDA, submitted as a “Prior Approval Supplement,” specifies an alternate drug product manufacturing site for previously approved ANDAs from Panelav Facility (F-I) – Alembic Pharma, Formulation Division IV, Jarod, Gujarat.
The Jarod Facility was inspected in December 2022 and this is the first product approval from that facility, according to a statement from the business.
The approved sANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Lyrica Capsules, of Upjohn.
Pregabalin Capsules are indicated for neuropathic pain, postherpetic neuralgia, and other indications, the statement concluded.
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