Alembic Gets USFDA Approval For Pregabalin Capsules
Alembic Pharmaceuticals on Thursday stated that it has received PAS (Prior Approval Supplement) approval from the US Food and 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 company said in a statement.
The sANDA, submitted as “Prior Approval Supplement," provides for an alternate drug product manufacturing site - Alembic Pharmaceuticals Limited, Formulation Division IV, Jarod, Gujarat, India for previously approved ANDA from Panelav Facility (F-I). This is the first product approval from Jarod Facility which was inspected in Dec 2022, the company's statement read.
The approved sANDA is therapeutically equivalent to the reference listed drug product (RLD), Lyrica Capsules, of Upjohn. Pregabalin Capsules are indicated for neuropathic pain, postherpetic neuralgia, and other indications.Pregabalin Capsules have an estimated market size of US$ 244 million for twelve months ending Sep 2022 according to IQVIA.
Alembic has a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.
