Sun Pharma gets USFDA approval for Prevacid generic drugs

16 September 2013 | News | By BioSpectrum Bureau

Sun Pharmaceutical Industries Ltd. announced that the US FDA 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.

Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg are therapeutic equivalent of Takeda's Prevacid Delayed-Released Capsules. These capsules have annual sales of approximately USD 430 million in the US. Lansoprazole Delayed-Release Capsules USP are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer.

In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, nephrology, gastroenterology, orthopaedics and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms.