USFDA approves Lupin’s Varenicline tablets

Indian multinational pharmaceutical firm Lupin Limited (Lupin) on Wednesday (December 6, 2023) introduced that it has obtained approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Varenicline Tablets.

The nod was given to 0.5 mg and 1 mg, to market a generic equal of Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V., Lupin introduced by way of an alternate submitting.

The product will likely be manufactured at Lupin’s Pithampur facility in India.

Varenicline Tablets, 0.5 mg and 1 mg are indicated to be used as an help to smoking cessation therapy.

Varenicline Tablets (RLD Chantix) had estimated annual gross sales of USD 430 million within the U.S. (IQVIA MAT October 2023).

(The article is revealed underneath a mutual content material partnership association betweenThe Free Press JournalandConnected to India)