Lupin gains FDA OK for 2 generics

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

The FDA has approved obeticholic acid tablets, 5 mg and 10 mg, which is a generic of Intercept’s Ocaliva.

This product will be manufactured at Lupin’s Nagpur facility in India.

The medication treats primary biliary cholangitis differently than ursodiol (also called ursodeoxycholic acid or UDCA).

Obeticholic acid tablets have a market value of roughly $262 million, according to IQVIA March 2023 data.

[Read more: Lupin receives tentative nod from FDA for DETAF]

Lupin’s subsidiary, Novel Laboratories has received approval from the FDA for diazepam rectal gel, 10 mg and 20 mg, Rectal Delivery System, a generic of Bausch Health’s Diastat AcuDial Rectal Delivery System.

Diazepam rectal gel is used to control seizures (i.e., seizure clusters, acute repetitive seizures) in patients who have epilepsy.

[Read more: Lupin receives FDA OK for generic Banzel]

Diazepam Rectal Gel had a market value of approximately $34 million, per IQVIA March 2023 data.