USFDA approves Alembic Pharma Albendazole Tablets
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-09-06 06:01 GMT | Update On 2024-09-06 06:01 GMT
Vadodara: Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Albendazole Tablets USP, 200 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), LAlbenza Tablets, 200 mg, of Impax Laboratories, Inc.
Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. It is also indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.
Alembic has a cumulative total of 214 ANDA approvals (186 final approvals and 28 tentative approvals) from USFDA.
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. 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.
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