Pharmaceutical Business review

APR, Labtec file for Zolmitriptan ODF approval in Europe

APR said Zolmitriptan ODF is a very thin polymeric film strip with a size of 3sqcm and 6sqcm for the 2,5mg and 5mg dosage strengths, respectively.

Zolmitriptan ODF once placed in the mouth, dissolves in a few seconds and is swallowed with the saliva without the need of water.

APR and Labtec said the oral dispersible film strip formulation containing anti-migraine drug Zolmitriptan is the second prescription product based upon their RapidFilm technology and is co-developed in collaboration with the Warren, New Jersey based Monosol Rx.

The product will be manufactured for Europe at Labtec´s production site in Hamburg, Germany.

Concurrently, the same partners are proceeding in the US to complete the required steps to obtain Marketing Approval by the FDA.