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 sANDA, submitted as “Prior Approval Supplement,” provides for an alternate drug product manufacturing site – Alembic Pharma, Formulation Division IV, Jarod, Gujarat, for previously approved ANDA from Panelav Facility (F-I). This is the first product approval from Jarod Facility which was inspected in December 2022, the company said in a statement.
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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