H.Q. Team
February 17, 2023: Glenmark Pharmaceuticals, a US-based company, has received a tentative second FDA approval for its oral drug to treat high blood pressure.
According to a BSE filing, the Saxagliptin tablets of 2.5 mg and 5 mg are the generic version of Onglyza1 Tablets, 2.5 mg and 5 mg, of AstraZeneca AB.
Glenmark’s first tentative approval letter for Saxagliptin tablets, 2.5 mg and 5 mg, was received on June 12, 2017.
The Onglyza® Tablets, 2.5 mg and 5 mg market clocked annual sales of approximately $122.3 million, according to IQVIATM sales data for the 12 months ending December 2022.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odour.
High blood glucose happens when the body has too little insulin or when the body can’t use insulin properly. If prolonged, hyperglycemia can lead to health problems affecting the eyes, kidneys, nerves and heart.
Glenmark’s current portfolio consists of 179 products authorized for distribution in the U.S. marketplace and 46 ANDAs pending approval with the US 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, according to the filing.
Glenmark Pharmaceuticals has a presence across branded, generics, and OTC segments, focusing on respiratory, dermatology and oncology therapeutic areas.
The company has ten manufacturing facilities spread across four continents and operations in over 80 countries.
