Sunday, December 30, 2007

Mylan Announces Final FDA Approval for Cetirizine Hydrochloride Tablets

PITTSBURGH, December 28, 2007 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.

Cetirizine HCl Tablets are the generic version of Pfizer's Zyrtec(R) Tablets, which had U.S. sales of approximately $1.4 billion for the 12 months ending Sept. 30, 2007.

This product will be shipped immediately.

No comments: