Content about Mikah Pharma

February 6, 2013

FDA approves Elite Pharmaceuticals' opioid painkiller

The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.

November 15, 2012

Shipments of generic version of Bontril PDM begins

Initial shipment of a generic appetite suppressant has started, the drug's manufacturer said Thursday.

NORTHVALE, N.J. — Initial shipment of a generic appetite suppressant has started, the drug's manufacturer said Thursday.

Elite Pharmaceuticals announced the initial shipment of phendimetrazine tartrate tablets in the 35-mg strength, a generic version of Valeant's Bontril PDM, under a manufacturing and supply agreement with Mikah Pharma. Actavis, recently acquired by Watson Pharmaceuticals, will distribute the drug as part of a distribution agreement between Mikah and Actavis.