Alembic Pharmaceuticals receives USFDA approval for Lacosamide Tablets
Lacosamide Tablets may not be indicated for certain other uses due to unexpired exclusivities for the reference listed drug product (RLD) for such uses.
lembic Pharmaceuticals Limited has received final approval for Lacosamide Tablets from the US Food and Drug Administration (USFDA). It is used for the treatment of partial-onset seizures in patients who are 4 years and above.
Partial seizures happen due to the abnormal electrical activity in only one part of the brain and include simple partial seizures, where a person remains fully aware and does not lose consciousness. A person may experience stiffening of muscles or sense things that are not actually present.
The USFDA approval is with reference to its Abbreviated New Drug Application (ANDA). The approval has been received for 50 mg, 100 mg, 150 mg, and 200 mg Lacosamide Tablets.
An ANDA is subject to review and approval of a generic drug product from the USFDA based on the data submitted to the regulator. An applicant may produce and market the generic drug product to provide a safer, efficacious, lower cost alternative to the brand name drug it references based on the approval.
The approved ANDA is therapeutically equivalent to RLD Vimpat Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of UCB, Inc.
According to IQVIA, Lacosamide Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, have an estimated market size of US$ 1.67 billion for twelve months ending December 2021.
Alembic has received year to date (YTD) 23 approvals which includes 16 final approvals and 7 tentative approvals. It has a cumulative total of 161 ANDA approvals with 139 final approvals and 22 tentative approvals from the USFDA.
