Alembic Pharma gets USFDA nod to market drug to treat epilepsy & seizures

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges today, Vadodara (Baroda) headquartered Alembic Pharmaceuticals Ltd said of having received receives USFDA Approval for Clonazepam Orally Disintegrating Tablets USP, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg.

The press release submitted by the company to the Indian Bourses said, Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clonazepam Orally Disintegrating Tablets USP, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Klonopin Orally Disintegrating Tablets, 0. 125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg, of Hoffmann-La Roche, Inc. (Roche). Clonazepam orally disintegrating tablet is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures.


In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam orally disintegrating tablets may be useful.

It is also  indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSMV.

Clonazepam Orally Disintegrating Tablets USP has an estimated market size of US$ 20 million for twelve months ending December 2018 according to IQVIA.


Alembic now has a total of 98 ANDA approvals (86 final approvals and 12 tentative approvals) from USFDA.

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907.

Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

Alembic is one of the leaders in branded generics in India.

Alembic’s brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.

Information about the company can be found at; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (BSE: 533573)

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