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news.The US Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals', a subsidiary of Mylan Inc, abbreviated new drug application (ANDA) for Nifedipine extended-release tablets USP, 30mg, 60mg and 90mg, the generic version of Bayer's Adalat CC tablets, a treatment for hypertension.
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Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers that affects the amount of calcium found in the heart and muscle cells and also relaxes blood vessels, which can reduce the amount of work the heart has to do.
Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3.
Nifedipine extended-release tablets are formulated in Nifedipine GITS.
Mylan claims that currently it has 161 ANDAs pending FDA approval, 45 of these pending ANDAs are potential first-to-file opportunities.
Mylan is a generic and specialty pharmaceutical company that provides products to customers in more than 140 countries and territories.