Alembic Pharmaceuticals Limited on Thursday announced that it has received Prior Approval Supplement (PAS) 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,” 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),” the company stated on Thursday.
This is the first product approval from Jarod Facility which was inspected in December this year.
According to the company, 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, anxiety disorders among others. The 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 the USFDA.
