Regulatory and Washington

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.

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.

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. 

NEW YORK — An annual event at the Virginia state General Assembly drew several students from a local pharmacy school.

Hampton University said 24 of its students visited the General Assembly in Richmond, Va., on Jan. 30 to participate in Virginia Pharmacy Day, organized every year by the Virginia Pharmacist Association. 

The event combined a health fair — with cholesterol, diabetes and blood pressure screenings — and legislative visits with state representatives to discuss pharmacy-related issues.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Celgene for treating the cancer multiple myeloma, the agency said Friday.

The FDA announced the approval of Pomalyst (pomalidomide) for patients whose disease has progressed after treatment with other cancer drugs.