FDA Denies Merck’s Request To Block Generic Versions of Nasonex

The Food and Drug Administration recently denied Merck & Co.'s citizen petition asking the agency not to approve applications for certain generic forms of Nasonex allergy nasal spray.

Merck, based in Whitehouse Station, N.J., filed the petition in July about abbreviated new drug applications for generic versions that contain a formulation different from Nasonex. Nasonex is a mometasone furoate (MF) monohydrate drug, and the company asked that FDA not approve MF anhydrate versions of the drug because of different active ingredients.

FDA denied Merck’s petition in a Dec. 7, 2012, letter, saying it disagrees the anhydrate form of MF ...