Latest News | Glenmark Pharma Gets Tentative USFDA Nod for Generic Regadenoson Injection
Get latest articles and stories on Latest News at LatestLY. Glenmark Pharmaceuticals on Monday said its US arm has received tentative approval from the country's health regulator for its generic Regadenoson injection.
New Delhi, Jan 17 (PTI) Glenmark Pharmaceuticals on Monday said its US arm has received tentative approval from the country's health regulator for its generic Regadenoson injection.
Regadenoson injection is given during the preparation for a radiologic examination of blood flow through the heart to test for coronary artery disease.
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The tentative approval granted by the United States Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA (Glenmark) is for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the company said in a statement.
It is the generic version of Lexiscan injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US Inc, it added.
Citing IQVIATM sales data for the 12 month period ending November 2021, the company said the Lexiscan® Injection, 0.4 mg/5 mL (0.08 mg/mL) market achieved annual sales of approximately USD 659.9 million.
The company said its current portfolio consists of 172 products authorized for distribution in the US marketplace and 47 abbreviated new drug applications (ANDAs) pending approval with the USFDA.
(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)