Regulatory and Washington

SILVER SPRING, Md. — A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration reported Friday. 

NEW YORK — The Agency for Healthcare Research and Quality has announced the winners of a competition it sponsored to increase awareness and use of evidence-based healthcare tools in retail health settings, the government agency said.

BAGSVÆRD, Denmark — The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.

Novo Nordisk said it received complete response letters from the FDA for Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart). The FDA issues a complete response letter when it has finished reviewing an application for a drug, but determines that the application can't be approved in its current form.

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

NEW YORK — Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.

NEW YORK — President Obama has re-nominated Marilyn Tavenner as administrator of the Centers for Medicare and Medicaid Services, according to published reports.

The Hill, a Washington-based newspaper that covers Capitol Hill, noted that Tavenner had received an endorsement from House majority leader Eric Cantor, R-Va., who had worked with her when she was in charge of the Medicaid program in his state. Still, she could face a tougher time in the Senate.

SILVER SPRING, Md. - The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

The FDA approved Macleods' pioglitazone hydrochloride tablets in the 15 mg, 30 mg and 45 mg strengths.

The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period that ended in August 2012, according to IMS Health.

MONMOUTH BEACH, N.J. — A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International.