Regulatory and Washington

SILVER SPRING, Md. — Food and Drug Administration principal deputy commissioner Joshua Sharfstein will leave the agency to become head of the Maryland Department of Health and Mental Hygiene, according to published reports.

The Washington Post reported Wednesday that Sharfstein, the FDA’s top official after commissioner Margaret Hamburg, had received an invitation to head the state health department from Gov. Martin O’Malley.

Before assuming his position at the FDA, Sharfstein served as head of the Baltimore City Health Department.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores Foundation is inviting health and pharmacy experts and other researchers to join the Herculean effort to improve patient adherence rates.

The invitation comes in the form of a new Request for Proposal, issued Tuesday by the NACDS Foundation. The foundation is seeking bids from research organizations to study primary medication nonadherence, which occurs when a patient fails to fill or pick up his or her newly prescribed medication.

CHADDS FORD, Pa. — The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.

The drug maker announced on Dec. 29 the approval of Fortesta (testosterone) gel, a treatment for men with low testosterone, which affects nearly 14 million men in the United States.

Endo said it planned to introduce Fortesta in the United States early this year.

SILVER SPRING, Md. — The Food and Drug Administration last week prompted the recall of two more products sold as supplements but adulterated with prescription medicines.

Drive Total Energy, headquartered in San Diego, recalled its Rock Hard Extreme and Passion Coffee dietary supplements. The FDA found that the products contained sulfoaildenafil, an analogue of sildenafil that is an FDA-approved drug used in the treatment of male erectile dysfunction.

NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.

MUMBAI, India — The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.

PRINCETON, N.J. — Sandoz has launched higher dosages of its authorized generic version of a hypertension drug, the generics division of Swiss drug maker Novartis said Monday.

Sandoz announced the launch of amlodipine besylate and benazepril in the 5-mg/40-mg and 10-mg/40-mg strengths. The company already marketed the drug in the 2.5-mg/10-mg, 5-mg/10-mg, 5-mg/20-mg and 10-mg/20-mg strengths.

The drug is an authorized generic of Lotrel, marketed by Novartis Pharmaceuticals. An authorized generic is a branded drug marketed under its generic name at a reduced price.

ATLANTA — The Food and Drug Administration declined to approve a treatment for diabetic eye disease made by Alimera Sciences, the drug maker said Dec. 23.

In its complete response letter, the FDA requested additional safety and efficacy data for the drug, Iluvien (fluocinolone acetonide intravitreal insert), a treatment for diabetic macular edema, a problem that commonly affects people with diabetes.