Received final approval from the FDA for its ANDA for Metformin HCl Oral Solution

Saptalis Pharmaceuticals, LLC today announced that it has received final approval from the FDA for its ANDA for Metformin HCl Oral Solution 500 mg/5mL. Metformin HCl oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. The product is the only generic version of Riomet®, Sun Pharmaceutical Industries, Inc. which in 2019, had annual sales of $15M (IQVIA). Saptalis was first generic company to file the ANDA containing a paragraph IV certification and successfully challenged the patent for Riomet®. The FDA granted the Company a 180-day period of marketing exclusivity. The Company will commercialize Metformin HCl Oral Solution in collaboration with its marketing & distribution partner Micro Labs, USA, Inc. and intends to ship the product before the end of March, 2020.

The release as fetched from its publisher. saptalis.com ↗