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Pharma major Sun Pharmaceutical Industries Ltd has said it filed Abbreviated New Drug Applications (ANDAs) for four products and received nine approvals from the US FDA in the first quarter this fiscal.
"In Q1 FY 14, the company filed ANDAs for 4 products, while it has received nine approvals from the US FDA. We now have 320 ANDAs approved for a total of 453 products filed with US FDA, and ANDAs for 133 products await approval. On a consolidated basis, we now have 791 patent filings with 503 granted patents," Sun Pharma Managing Director Dilip Shanghvi said in a statement.
Sun Pharma also announced that the US FDA has granted its subsidiary final approval for its ANDA for generic version of Prevacid, Lansoprazole delayed-release capsules.
Lansoprazole delayed-release capsules USP, 15 mg and 30 mg, are therapeutic equivalents of Takeda's Prevacid delayed- released capsules.
These capsules have annual sales of approximately $430 million in the US, the company statement said here.
Lansoprazole delayed-release capsules USP are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer. Prevacid is a registered trademark of Takeda Pharmaceuticals USA, Inc.
Sun Pharmaceutical manufactures and markets a large basket of pharmaceutical formulations.
