By: IPP Bureau
Last updated : January 17, 2022 11:09 am
The company has 47 ANDA's pending approval with the U.S.FDA
Glenmark Pharmaceuticals has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan®1 Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.
According to IQVIATM sales data for the 12 month period ending November 2021, the Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL) market2 achieved annual sales of approximately US $ 659.9 million.
Glenmark’s current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 47 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.