Mylan Launches Generic Zyvox Tablets

Mylan N.V. announced the U.S. launch of Linezolid Tablets, 600 mg, which is the generic version of Pfizer's Zyvox^® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in adults and children for the treatment of certain infections caused by susceptible Gram-positive bacteria.

Linezolid Tablets, 600 mg, had U.S. sales of approximately $457.8 million for the 12 months ending Sept. 30, 2015, according to IMS Health. 

Currently, Mylan has 269 ANDAs pending FDA approval representing $100.8 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $35.6 billion in annual brand sales, for the 12 months ending June 30, 2015, according to IMS Health.

Mylan Receives U.S. FTC Clearance

Mylan N.V. announced the U.S. Federal Trade Commission ("FTC") has cleared the company's proposed transaction to acquire Perrigo Company plc subject to Mylan's divestiture of certain products following the consummation of the offer. The FTC clearance represents the final regulatory clearance needed by Mylan to close its acquisition of Perrigo and represents the last remaining condition that needs to be satisfied for the successful completion of the offer other than the acceptance condition. 

Under the terms of Mylan's offer, Perrigo shareholders will receive $75 in cash and 2.3 Mylan ordinary shares for each Perrigo ordinary share. On September 14, 2015 Mylan officially commenced its formal offer to acquire all outstanding ordinary shares of Perrigo. 

The offer is being made in accordance with Mylan's announcement (dated April 24, 2015 and amended on April 29, 2015 and on August 13, 2015) pursuant to Rule 2.5 of Irish Takeover Rules that set forth Mylan's legally binding commitment to commence an offer and the Offer to Exchange / Prospectus (being the offer document for the purposes of the Irish Takeover Rules) dated September 14, 2015.  The offer and withdrawal rights are scheduled to expire at 1:00 P.M. (Irish time)/8:00 A.M. (New York City time) on November 13, 2015, unless the offer is extended with the consent of the Irish Takeover Panel.  The acceptance condition for the offer requires greater than 50% of Perrigo ordinary shares to have been tendered into the offer.