Specialty Pharmacy

SILVER SPRING, Md. — The Food and Drug Administration has approved two new drugs for pancreatic disorders, the agency said Thursday.

The FDA announced the approval of Aptalis Pharma's Ultresa and Viokase, both generically known as pancrelipase. Ultresa is a delayed-release capsule for children and adults with cystic fibrosis, which affects the lungs and other organs, while Viokase is meant for use with a proton-pump inhibitor in adults who can't digest food because of pancreatitis or surgical removal of the pancreas.

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.

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.

PARSIPPANY, N.J. — Lowering health costs will require a greater understanding of differences between two distinct groups of patients, according to a new study, which also noted a growing availability of specialty drugs for complex and chronic conditions outside the hospital.

PHOENIX — A division of specialty pharmacy provider The Apothecary Shops has become the exclusive distributor of a drug used in glaucoma surgery, the company said.

Apothecary Shop Wholesale has received exclusive distribution rights for Mobius Therapeutics' drug Mitosol (mitomycin), which the Food and Drug Administration approved earlier this month.

DEERFIELD, Ill. — Walgreens Specialty Pharmacy on Thursday released data showing that both patients and their health plans can realize savings of up to 60% on the cost of infused specialty medications by choosing alternate treatment sites. The cost savings was the key finding from new data being presented at the 2012 Pharmacy Benefit Management Institute Annual Drug Benefit Conference in Scottsdale, Ariz.


SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

The FDA announced the approval of Menlo Park, Calif.-based Corcept Therapeutics' Korlym (mifepristone) for endogenous Cushing's syndrome, a disorder that results from overproduction of cortisol, a steroid hormone that increases blood-sugar levels.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.

Mylan said Thursday that the FDA had tentatively approved Mylan Labs' abacavir sulfate and lamivudine tablets in the 60 mg/30 mg strength. The drug is a generic version of Viiv Healthcare's Epzicom and was approved under the President's Emergency Plan for AIDS Relief. The drug will only be available for purchase in certain developing countries outside the United States.