Regulatory and Washington

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

WASHINGTON — The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients. Those two guidelines will help the agency use adverse event reports in overseeing dietary supplement products, the GAO stated.

WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

WASHINGTON — A survey of 114 researchers, government officials, insurers, employers, business leaders and trade groups found nearly one-third say comparative effectiveness research will have a "moderate improvement" on healthcare decision making over the next 12 months.

SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

NEW YORK — In spite of a court ruling striking down a ban on large-sized sugary drinks, New York mayor Michael Bloomberg has another health initiative in the works: a requirement that retailers hide tobacco products.

Bloomberg's legislation, which would make New York the first city to keep tobacco products out of the sight of customers, will go to the city council for consideration. The New York Times noted that Bloomberg skipped this procedure with the soft drink rule.

PITTSBURGH — The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

Mylan announced the approval of levalbuterol inhalation solution in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths. The company has begun shipping the product.

The drug is a generic version of Sunovion's Xopenex inhalation solution, which is used to treat bronchospasm in patients ages 6 years and older with reversible obstructive airway disease.

HOFFMAN ESTATES, Ill. — The Environmental Protection Agency has given Sears Holdings a 2013 Energy Star Partner of the Year - Sustained Excellence Award, the company said Monday.

Sears Holdings, which operates Kmart, said its efforts to promote sustainability and energy efficiency would be recognized at a ceremony in Washington on March 26.

The company has been an Energy Star partner since 1998.