Alembic Pharmaceuticals announced that it has received final approval from the US Food and 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. 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.