Content about Pharmaceutics

PITTSBURGH A U.S. District Court has blocked Canadian generic drug maker Apotex from selling generic versions of an antidepressant drug.

Generic drug maker Mylan said Tuesday that it had obtained a temporary restraining order from the U.S. District Court for the District of New Jersey prohibiting Apotex from selling generic versions of the drug Paxil CR (paroxetine hydrochloride), an extended-release formulation of GlaxoSmithKline’s Paxil.

ST. LOUIS Starting Monday, K-V Pharmaceutical will ship its first product since it withdrew several products in 2008 and 2009 due to manufacturing problems, the drug maker said.

K-V said the Food and Drug Administration had given it approval to ship its Micro-K potassium chloride product following the completion of inspections of its manufacturing plant.

NEW YORK Efforts by two generic drug makers to market a generic version of a drug for multiple sclerosis hit an obstacle this week in a U.S. District Court.

The U.S. District Court for the Southern District of New York denied a motion for summary judgment filed by Sandoz and Momenta Pharmaceuticals that patents covering Teva Pharmaceutical Industries’ drug Copaxone (glatiramer acetate) are invalid due to indefiniteness.

AMITYVILLE, N.Y. Hi-Tech Pharmacal had $40.4 million in sales during its fiscal first quarter ended July 31, the generic drug maker said Thursday. The numbers amounted to a decrease of $3 million from the same period in 2009.

LONDON Swiss drug maker Lonza will help British drug maker GlaxoSmithKline manufacture five biotech drugs in early- and mid-stage clinical trials, the two companies said Wednesday.

Lonza will manufacture clinical trial batches of the drugs, all monoclonal antibodies in phase-1 and phase-2 testing, and provide additional access to manufacturing capacity so GSK can fulfill future demands. The two companies said other details of the agreement remain confidential.

PEAPACK, N.J. The generics subsidiary of Pfizer is launching a new business focused on authorized generics.

Greenstone announced Tuesday the launch of the Authorized Generics Alliance, which it said would combine its business model and 17 years of experience in the generics market with the expertise of other drug makers to market authorized generics in the United States under the Greenstone label.

MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals has applied for Food and Drug Administration approval for a version of a drug used to treat eye diseases, Watson said Tuesday.

NORTH WALES, Pa. Teva Pharmaceuticals has launched a generic treatment for epileptic seizures.

The world’s largest generic drug maker announced Wednesday the launch of diazepam rectal gel, a generic version of Valeant Pharmaceuticals’ Diastat AcuDial. The drug is administered via rectal syringe and is available in 2.5-mg, 10-mg and 20-mg strengths.

LONDON The Food and Drug Administration has pushed back its review date for a drug made by GlaxoSmithKline and Valeant Pharmaceuticals.

The FDA has not yet completed the review of the new drug application for ezogabine, a drug designed to treat epileptic adults with partial onset seizures, after a formal risk evaluation and mitigation strategy was submitted to the agency from GSK and Valeant, per its request.

The FDA is expected to review the application by Nov. 30.

SAN DIEGO The U.S. drug market will present opportunities as well as uncertainties over the next decade, according to remarks made by IMS Health VP industry relations Doug Long at the National Association of Chain Drug Stores’ 2010 Pharmacy and Technology Conference held here on Monday.

BRISTOL, Tenn. Jeffrey Bailey has been appointed as King Pharmaceuticals' chief commercial officer, leading all sales, marketing, managed care, sales operations and business analytics for the drug maker.

BRISTOL, Tenn. Jeffrey Bailey has been appointed as King Pharmaceuticals' chief commercial officer, leading all sales, marketing, managed care, sales operations and business analytics for the drug maker.