Content about Elite Pharmaceuticals

February 6, 2013

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

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.

April 7, 2011

Elite Pharmaceuticals has begun shipping an appetite suppressant for reducing weight in obese patients, the company said Thursday.

NORTHVALE, N.J. — Elite Pharmaceuticals has begun shipping an appetite suppressant for reducing weight in obese patients, the company said Thursday.

The drug maker announced the initial shipment of phentermine hydrochloride tablets in the 37.5-mg strength. The drug is a generic version of Teva’s Adipex-P.

Adipex-P and generic versions had sales of about $40 million in 2010, according to IMS Health.

The shipment was made under a collaborative agreement with precision dose and its subsidiary, TAGI Pharma.

February 18, 2011

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



February 4, 2011

The Food and Drug Administration has approved a generic weight-loss drug made by Elite Pharmaceuticals.

NORTHVALE, N.J. — The Food and Drug Administration has approved a generic weight-loss drug made by Elite Pharmaceuticals.

Elite announced Friday the approval of phentermine hydrochloride in the 37.5-mg strength, a generic version of Teva’s Adipex-P.

Branded and generic versions of the drug had sales of around $40 million in 2010, according to Elite.