New Delhi: Drug firm Sun Pharmaceutical Industries today said it has received final approval from the US health regulator for its generic Lansoprazole delayed- release capsules used for treating duodenal ulcer.
"The United States Food and Drug Administration (USFDA) has granted its subsidiary final approval for its abbreviated new drug applications (ANDA) for generic version of Prevacid, Lansoprazole Delayed-Release Capsules USP 15 mg and 30 mg," Sun Pharmaceutical Industries said in a statement.
Prevacid is a registered trademark of Takeda Pharmaceuticals US, Inc.
"These capsules have annual sales of approximately USD 430 million in the US," Sun Pharma said.
Lansoprazole delayed-release capsules USP are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer, it added.
The Mumbai based Sun Pharmaceutical Industries manufactures and markets pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.