Regulatory and Washington

COLUMBUS, Ohio — A federal court has turned down Cardinal Health's request for an injunction against the Drug Enforcement Administration's suspension of the its ability to ship controlled medications from one of its distribution centers, the company said Wednesday.

Reggie Walton, a judge for the U.S. District Court for the District of Columbia, ruled against Cardinal's request to enjoin the DEA from preventing the company from shipping controlled substances from the distribution center, in Lakeland, Fla.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Tuesday expressed support for H.R. 4095, “The Online Pharmacy Safety Act,” which the organization said will help consumers protect themselves against the growing threat of illegitimate online drug sellers.

NACDS sent a letter in support of the bill to its sponsors, Reps. Bill Cassidy, R-La., and Mike Ross, D-Ark. 

The bill requires the Department of Health and Human Services to create a public registry of law-abiding online pharmacy websites for consumer use.

WESTON, Mass. — The Food and Drug Administration has approved two separate dosing innovations for multiple sclerosis patients that are being treated with a Biogen Idec drug.

Biogen Idec said the FDA approved Avonex pen, the first single-use, once-weekly intramuscular autoinjector approved for MS, and a dose titration regimen, which gradually escalates the dose of Avonex at treatment initiation. The drug maker said the new offerings are designed to improve the treatment experience.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.

Hi-Tech announced the approval of levetiracetam oral solution in the 100 mg-per-milliliter strength. The drug is a generic version of UCB Pharma's Keppra oral solution and is used to treat partial onset seizures in people ages 16 years and older.

Various versions of the drug had sales of $62 million in 2011, according to IMS Health. Hi-Tech said it plans to launch the drug in May.

RARITAN, N.J. — The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.

J&J's Janssen Research & Development division announced that the FDA had given the designation to Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of certain types of heart attacks in patients with acute coronary syndrome, which 1.2 million Americans are diagnosed with every year.

NEW YORK — GlaxoSmithKline can sell an authorized generic of its antidepressant drug to Toronto-based drug maker Apotex, a U.S. judge ruled.

According to a Bloomberg Businessweek report, U.S. District Court judge Joe Pisano ruled the agreement was valid.

SILVER SPRING, Md. — Drugs widely used to treat cholesterol may cause increases in blood sugar and other symptoms, the Food and Drug Administration said Tuesday.

WASHINGTON — An organization that certifies pharmacy technicians is starting a program designed to encourage more technicians to get certified.

The Pharmacy Technician Certification Board announced Tuesday the launch of the Employer Partnership Program, which it said was for retail and health-system pharmacies that want to encourage technicians to participate in the PTCB certification program. North Carolina regional chain Kerr Drug already has joined the program, according to PTCB.