Lacosamide tablets may not be indicated for certain other uses due to unexpired reference drug exclusivities (RLD) for such uses.
Alembic Pharmaceuticals Limited has received final approval for Lacosamide Tablets from the United States Food and Drug Administration (USFDA). It is used to treat partial onset seizures in patients 4 years of age and older.
Lacosamide tablets may not be indicated for certain other uses due to unexpired reference drug exclusivities (RLD) for such uses.
Partial seizures occur because of the abnormal electrical activity in only one part of the brain and include simple partial seizures, in which a person remains fully conscious and does not lose consciousness. A person may experience stiffening of muscles or feel things that are not really there.
The USFDA’s approval is with reference to the Abbreviated New Drug Application (ANDA). 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 from the USFDA based on the data submitted to the regulator. An applicant may manufacture and market the generic drug to provide a safer, more effective, and less expensive alternative to the brand name drug it refers to based on the approval.
The approved ANDA is therapeutically equivalent to RLD Vimpat Tablets, 50mg, 100mg, 150mg and 200mg from UCB, Inc.
According to IQVIA, lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg, have an estimated market size of $1.67 billion for twelve months ending December 2021.
Alembic has received 23 approvals to date, including 16 final approvals and 7 preliminary approvals. It has a cumulative total of 161 ANDA approvals with 139 final approvals and 22 preliminary approvals from the USFDA.
Alembic, one of the leaders in branded generics in India, manufactures and markets generic pharmaceuticals worldwide. Its research and manufacturing facilities are approved by regulatory agencies of many developed countries, including the USDA.
This post Alembic Pharmaceuticals Receives USFDA Approval for Lacosamide Tablets
was original published at “https://www.financialexpress.com/healthcare/pharma-healthcare/alembic-pharmaceuticals-receives-usfda-approval-for-lacosamide-tablets/2467154/”
