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news.Mylan Pharmaceuticals has received FDA final approval for its abbreviated new drug application (ANDA) for Nifedipine extended-release tablets USP, 30mg, 60mg and 90mg, the generic version of Pfizer's Procardia XL tablets, a treatment for angina and/or hypertension.
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Procardia XL extended release tablet is designed to provide nifedipine at an approximately constant rate over 24 hours. The controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility.
Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers.
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 currently has 137 ANDAs pending FDA approval, 41 of these pending ANDAs are potential first-to-file opportunities.