Alembic Pharma gets USFDA nod for generic product

Alembic Pharmaceuticals has received approval from the USFDA to market Albendazole Tablets USP (200 mg), a generic drug for treating infections caused by worms. The tablets are equivalent to Impax Laboratories' Albenza and are used for conditions ...

Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic drug used to treat infections caused by worms.

The company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Albendazole Tablets USP (200 mg), the drug maker said in a statement.

The approved ANDA is therapeutically equivalent to Impax Laboratories, Inc.'s LAlbenza tablets, it added.


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 Pharma shares on Thursday ended 2.79 per cent higher at Rs 1,145.80 apiece on the BSE.
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