Indian pharmaceutical and biotechnology conglomerate, Cipla Limited, has recently announced receiving a final approval for marketing its Metoprolol ER tablets from the United States Food and Drug Administration (USFDA).
Sources close to the matter state that Cipla, at its recent BSE (Bombay Stock Exchange) filing, announced that the company has received a positive affirmation from the USFDA for its Abbreviated New Drug Application for the Metoprolol tablets that can be used to treat hypertension and several other cardiac conditions, in the doses of 50 mg, 100 mg and 200 mg.
The USFDA approved product is a therapeutic equivalent of Aralez Pharmaceuticals, Inc’s, Toprol XL, a drug used to treat high BP (blood pressure), acute chest pain due to poor heart blood flow and several other conditions involving an unusually fast heart rate, the company said.
For the record, Cipla is a globally renowned pharmaceutical company, dedicated to generic, high-quality, and branded medicines. The company is trusted by healthcare professionals and patients across geographies for over the last 8 decades, strengthening its leadership in the India pharmaceutical industry.
Reportedly, the company aims at strengthening its global focus by consolidating and deepening its presence in the key markets of India, South Africa, the U.S. and other economies of the developing world, cite sources.
According to The Economic Times, Cipla claims that the its Metoprolol succinate extended-release tablets, similar to Aralez Pharmaceuticals’ Toprol XL, are indicated for the treatment of hypertension, lower blood pressure and Angina Pectoris (chest pain due to coronary heart disease). Cipla said that the Toprol XL and its generic equivalents reportedly had U.S. sales of around $464 million for the 12-month period in 2018.
As per recent market reports, shares of Cipla, after the USFDA approval, were trading 3.52 percent higher at Rs 624.70 apiece on the recent BSE filling.