Glenmark Pharma receives ANDA tentative approval for Regadenoson injection

Glenmark Pharmaceuticals Inc., USA has received tentative approval by the United States Food & Drug Administration (US FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.

Glenmark's current portfolio consists of 172 products authorized for distribution in the U.S. marketplace.

The company stated that it continues to identify and explore external development partnerships to accelerate the growth of its existing pipeline and portfolio.

The Lexiscan injection, 0.4 mg/5 mL (0.08 mg/mL) market achieved annual sales of approximately $659.9 million, according to IQVIA sales data for the 12 month period ending November 2021.

FPJ Shorts

Disha Salian Death Case: 5 Years On, Investigation Still Delayed Amid Political Claims And Ongoing Legal Challenges

Disha Salian Death Case: Bombay HC Seeks Medical Reports Before Considering Plea For FIR; State Awaiting Fresh Forensic Findings

Bombay HC Questions ‘Malafide’ In Scaling Down Zeeshan Siddique’s Security After Father Baba Siddique’s Murder; Seeks Committee Records

Bombay HC Quashes Case Against Chanda Kochhar, 4 ICICI Officials In PMC Octroi Evasion Row; Proceedings To Continue Against Bank

(With inputs from ANI)