Mylan Launches Generic Microner Tablets, 0.35mg

Mylan Inc.

today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Norethindrone Tablets USP, 0.35 mg. Norethindrone Tablets USP, 0.35 mg, are the generic version of Janssen Pharmaceuticals, Inc.'s Micronor® Tablets, 0.35 mg (28-Day Cycle), which are indicated for the prevention of pregnancy. Mylan's partner, Famy Care Ltd., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Norethindrone Tablets USP, 0.35 mg, had U.S. sales of approximately $57.2 million for the 12 months ending March 31, 2013, according to IMS Health. Currently, Mylan has 176 ANDAs pending FDA approval representing $83 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $22.5 billion in annual brand sales, for the 12 months ending December 31, 2012, according to IMS Health.