CANONSBURG, Pa. (AP) – Mylan Inc. confirmed that it has been sued by Shionogi Pharma Inc. and Cima Labs Inc. over an application filed with the Food and Drug Administration to make a generic version of Orapred, a steroid used to reduce inflammation in asthma and other conditions.
The Canonsburg, Pa., company said it believes it is the first company to have filed a substantially complete abbreviated new drug application for three doses of the drug, and it expects to qualify for six months of marketing exclusivity after receiving FDA approval.
Orapred ODT had U.S. sales of about $28 million for the 12 months that ended Sept. 30. Mylan currently has 164 abbreviated new drug applications pending with the FDA.
Date: December 20, 2010
Source: Associated Press