Specialty Pharmacy

DUBLIN — A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.

Shire said the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of Firazyr (icatibant) for treating acute hereditary angioedema attacks in adults. The committee also voted 11-1 to recommend approval of self-administration of the drug by patients.

HAE is a genetic and potentially fatal immune system disorder that causes swelling of the face and airways and result in airway blockage.

GALASHIELS, Scotland, and BEDMINSTER, N.J. — ProStrakan has received approval from the Food and Drug Administration to market an ointment designed to treat moderate to severe pain associated with chronic anal fissures.

The drug maker, which is a subsidiary of Kyowa Hakko Kirin, said that it received regulatory approval for Rectiv (nitroglycerin) ointment 0.4%. Rectiv currently is the only FDA-approved prescription product for patients with this condition. ProStrakan expects Rectiv to be available in the United States in first quarter 2012.

COVINGTON, Ky. — Omnicare has added two members to its board of directors.

The company said that Mark Emmert and Barry Schochet will serve as independent directors. Emmert serves as president of the National Collegiate Athletic Association, while Schochet serves as president and CEO of BPS Health Ventures, a healthcare consulting and investment firm.

LAKE MARY, Fla. — Axium Healthcare Pharmacy was named the recipient of a 2011 SMART Award in the healthcare and life sciences category by the Association for Corporate Growth's Orlando chapter, the specialty pharmacy provider announced last week.

Each year, ACG Orlando presents SMART Awards as part of its continuing commitment to facilitate relationships among middle-market companies, capital sources and professionals active in corporate finance throughout Central Florida, Axium said. ACG Orlando hosted its fifth annual SMART Awards luncheon in late May.

NEW YORK — The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.

Pfizer and Acura Pharmaceuticals said that their drug Oxecta (oxycodone HCl, USP tablets) is the first tamper-resistant medication designed to deter abuse and misuse with Aversion technology, which is being licensed by Pfizer from Acura.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new formulation of an injectable drug made by Abbott for prostate cancer.

Abbott announced Monday the approval of a 45-mg, six-month formulation of Lupron Depot (leuprolide acetate) for advanced prostate cancer. Previous formulations have allowed patients to receive the drug every month or every three or four months.

The overall growth in drug spending for 2010 was 3.7%, according to the latest drug trend report by pharmacy benefit manager Medco Health Solutions. The lower increase 
was primarily due to higher rates of generic drug dispensing — more than 71% of drugs dispensed were generics. 


TARRYTOWN, N.Y. — A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

Regeneron said Friday that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended approval of Eylea (aflibercept) ophthalmic solution for the treatment of a form of age-related macular degeneration, also known as wet AMD. The disease causes abnormal growth of new blood vessels in the eye.