Market Overview

Mylan Announces Famy Care Received Final FDA Approval for ANDA for Levonorgestrel, Ethinyl Estradiol Tablets

Share:
Related MYL
Benzinga's Weekend M&A Chatter
Mylan Confirms USPTO Institutes Inter Partes Review Proceedings vs Two Copaxone 40 mg/mL Dosing Patents
Mylan (Investor's Business Daily)

Mylan Inc. (Nasdaq: 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.

Posted-In: News FDA

 

Related Articles (MYL)

View Comments and Join the Discussion!

Get Benzinga's Newsletters