Regulatory and Washington

PHILADELPHIA — The changing healthcare environment and the challenges and opportunities of specialty pharmacy were the biggest themes at Acro Pharmaceutical Services' sixth annual Payer and Managed Care Symposium in Philadelphia last Thursday.

Representatives from drug makers and across the specialty pharmacy space met at the Hyatt at the Bellevue to discuss a wide variety of topics related to specialty pharmacy.

SILVER SPRING, Md. — A single lot of a congestion-relief product has been recalled due to bacterial contamination found in a sample, the Food and Drug Administration said Wednesday.

PITTSBURGH — The Food and Drug Administration has approved a generic malaria drug made by Mylan, the drug maker said Tuesday.

Mylan announced the approval of quinine sulfate capsules in the 324-mg strength and has begun shipping it. The drug is a generic version of Mutual Pharmaceutical's Qualaquin and is used to treat uncomplicated Plasmodium falciparum malaria.

Various versions of the drug had sales of about $31.9 million during the 12-month period ended in September 2012, according to IMS Health.

SPRINGFIELD, Va. — The head of the American Pharmacists Association has been tapped as the chairman of the Pharmacy Quality Alliance, the PQA said Tuesday.

The PQA announced the appointment of APhA EVP and CEO Thomas Menighan, who will succeed Judith Cahill, who has served on the organization's board since its 2006 inception, including a recently completed two-year stint as chairwoman.

NEW YORK — Drug maker Merz Pharmaceuticals is suing Par Pharmaceutical over the latter's attempt to market a generic drug for cerebral palsy patients, according to published reports.

Bloomberg reported that Merz sued Par in the U.S. District Court for the District of Delaware after Par attempted to apply for Food and Drug Administration approval for a generic version of Cuvposa (glycopyrrolate) oral solution, used to treat severe drooling in cerebral palsy patients.

The drug received FDA approval this year, and Merz bought rights to the drug in August.

SILVER SPRING, Md. — The Food and Drug Administration has approved two generic versions of a drug to treat HIV, according to agency records.

The FDA approved abacavir sulfate tablets in the 300-mg strength made by Apotex and Aurobindo.

The drug is a generic version of Viiv Healthcare's Ziagen.

Interested in this topic? Sign up for our weekly DSN Collaborative Care e-newsletter. 

LONDON — The Food and Drug Administration has approved a new four-strain flu vaccine made by GlaxoSmithKline, the drug maker said.

GSK announced the approval of its Fluarix Quadrivalent (influenza virus vaccine) for children and adults against seasonal influenza subtypes A and B. The company said the vaccine was the first for intramuscular injection that protects against four strains of the virus.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a new drug to treat a rare but serious endocrine disorder.

Swiss drug maker Novartis announced the approval of Signifor (pasireotide), an injectable drug for treating Cushing's disease in adults for whom pituitary surgery is not an option or has not been curative. Novartis said Signifor was the first drug to be approved in the United States that addresses the disease's underlying mechanism.