Mylan’s ANDA for Clopidogrel Tablets Gets FDA Approval

Mylan Pharmaceuticals has revealed that the US Food and Drug Administration has approved its abbreviated new drug application for Clopidogrel tablets in 75mg and 300mg strengths.

Clopidogrel tablets are currently marketed in the United States by Bristol-Myers Squibb and Sanofi-Aventis under the brand name Plavix and are used in treating patients with a history of myocardial infarction, stroke or established peripheral arterial disease.

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Mylan Pharmaceuticals said that it will be distributing the 75mg strength of the tablets in a bottle form while the 300mg strengths will be exclusively distributed by Mylan Institutional in unit dose packs of 30 tablets.

Source-Medindia

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