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Alembic receives FDA nod for 2 generics

The FDA has approved Alembic's generic Albenza and generic Invega.
Levy

Alembic has received The Food and Drug Administration’s clearance for two generics.

The company obtained approvel for albendazole tablets, 200 mg, which is the generic of Impax's Albenza. 

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. 

[Read more: Alembic intros generic Perforomist]

Alembic also received the FDA’s permission for its generic version of Paliperidone extended-release tablets, used to treat schizophrenia. The approved strengths are 1.5 mg, 3 mg, 6 mg and 9 mg, and the product is therapeutically equivalent to Janssen's Invega. 

Paliperidone also is indicated for schizoaffective disorder.  

Paliperidone tablets had a market value of roughly $48 million for the 12 months ending June 2024, per IQVIA data.

[Read more: Alembic unveils 2 generics]

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