FDA gives tentative approval for Singulair generic

PITTSBURGH Mylan has received tentative approval from the Food and Drug Administration for its generic version of a drug used to treat allergies and asthma.

Mylan announced Friday that the FDA had given the tentative approval to its montekulast sodium tablets in the 10-mg strength. The tablets are a generic version of Merck & Co.’s Singulair.

Singulair had U.S. sales of $2.6 billion for the 12 months ended March 31, according to IMS Health data.