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Mylan Inc.
MYL today
announced that its partner Famy Care Ltd. has received final approval from the
U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug
Application (ANDA) for Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15
mg/0.03 mg. This product is the generic version of Teva Branded Pharmaceutical
Products' Nordette® 28 Tablets, which are indicated for the prevention of
pregnancy in women who elect to use this product as a method of
contraception.(1) The product will be distributed in the U.S. by Mylan
Pharmaceuticals Inc., and the company is shipping product immediately.
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, had U.S.
sales of approximately $60.4 million for the 12 months ending Sept. 30, 2012,
according to IMS Health.
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