FDA Accepts Resubmitted NDA for Levadex, Grants Orphan Status to New Leukemia Drug

In recent new drug developments, the Food and Drug Administration accepted a resubmitted new drug application for the migraine drug Levadex and granted orphan drug designation to Oxigene’s new leukemia drug.

Also, Ranbaxy Laboratories has launched the acne drug Absorica in the United States.

MAP Pharmaceuticals Inc. Nov. 21 announced that FDA has accepted its resubmitted new drug application for its migraine drug Levadex (dihydroergotamine) inhalation aerosol. MAP, which is based in Mountain View, Calif., submitted the original application in June 2011 (9 PLIR 686, 6/3/11).

FDA has classified the resubmission as a complete Class 2 response to ...