Lupin gets USFDA approval for generic Cymbalta capsules

Drug maker Lupin today said it has received approval from the US health regulator to market Duloxetine Hydrochloride capsules, used to treat major depressive disorder, in the American market.

The company has received tentative approval from the US Food and Drug Administration (USFDA) for its Duloxetine Hydrochloride Delayed-release (HCl DR) capsules in strengths of 20 mg, 30 mg and 60 mg, Lupin said in a statement.

The Mumbai-headquartered firm's capsules are the generic equivalent of Eli Lily's Cymbalta Delayed-release capsules, it added.

According to IMS Health data, Cymbalta HCl DR capsules had annual US sales of nearly $3.5 billion for 12 months to September, it said.

 

Duloxetine HCl DR capsules are indicated for the treatment of various ailments including major depressive disorder and generalised anxiety disorder (GAD).

Shares of Lupin today closed at Rs 441.10 on the BSE, down 0.62% from its previous close.