Insomnia Archives - Page 16 of 16 - MPR


NDA resubmitted for Intermezzo for insomnia

Transcept Pharmaceuticals announced that it has resubmitted its New Drug Application (NDA) to the FDA seeking approval of Intermezzo (zolpidem tartrate sublingual tablet) for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

REMS approved for Nuvigil and Provigil

Cephalon announced that the FDA has approved Risk Evaluation and Mitigation Strategies (REMS) for its medications Nuvigil (armodafinil tablets) and Provigil (modafinil tablets).