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28 Dec 2011

Mylan Launches Generic Version of Teveten Tablets

Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification to the FDA for Eprosartan Mesylate Tablets.

Mylan Inc. announced Tuesday that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base).

 

The product is the generic version of Abbott Laboratories' Teveten? Tablets, which are used to treat hypertension. Mylan is shipping this product immediately.

 

Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification to the FDA for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base), and was awarded 180 days of marketing exclusivity.

 

Eprosartan Mesylate Ta

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