Regulatory and Washington

PARSIPPANY, N.J. — The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.

ALEXANDRIA, Va. — In an effort to encourage the safe storage and proper disposal of prescription medicines, a campaign supported by the National Community Pharmacists Association has launched a public service announcement aimed at Oklahoma City residents.

LAKE FOREST, Ill. — Generic drug maker Hospira has joined the country's largest lobby for the generic drug industry, the company said.

Hospira, which specializes in generic injectables and infusion technology, announced that it had joined the Generic Pharmaceutical Association. In addition to generic pharmaceuticals, the company also makes biosimilars for the European market.

ALEXANDRIA, Va. — The Supreme Court has sent a lawsuit challenging cuts to California's Medicaid program back to a lower court.

The high court ruled 5-4 in the case of Douglas v. Independent Living Center of Southern California that healthcare providers could challenge Medicaid reimbursement cuts under the U.S. Constitution's supremacy clause. The decision returns the case to the Ninth Circuit Court of Appeals, which had originally ruled that the providers had standing to sue.

MOUNTAIN VIEW, Calif. — A panel of experts at the Food and Drug Administration has recommended approval for an obesity drug that so far had not met much success at the agency.

Vivus announced Wednesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving Qnexa (phentermine and topiramate) for obesity in adults. The FDA is not bound by advisory committee votes when it decides whether or not to approve a drug, but usually follows them.

WASHINGTON — Joseph Williams, the former CEO of Warner-Lambert, was named the recipient of the American Pharmacists Association Foundation's 2012 Jacob W. Miller Award, the APhA Foundation said.

The organization said it recognized Williams for his leadership and service to the APhA Foundation capital campaign and advisory committee. Williams also served as APhA honorary president from 2004 to 2005.

HAYWARD, Calif. — The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

Impax Pharmaceuticals, the branded products division of Impax Labs, said it filed its NDA for the investigational drug IPX066, an extended-release capsule formulation of carbidopa-levodopa, for review in December 2011. IPX066 has been licensed to GlaxoSmithKline for countries outside the United States and Taiwan for development and marketing.

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.