Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.

Merck’s Label Standardization Project includes the revision of 34 container labels for 16 drugs, all orally administered pills. These include the cardiovascular drugs Cozaar (losartan) and Hyzaar (losartan and hydrochlorothiazide), the diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin), the allergy and asthma drug Singulair (montelukast), the HIV drug Isentress (raltegravir) and others.

NEW YORK — A drug for chronic obstructive pulmonary disease made by Forest Labs will be available by the middle of this month, Forest said Thursday.

Daliresp (roflumilast) recently received approval from the Food and Drug Administration as a treatment to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Forest said Daliresp, a daily oral tablet, is the first and only approved drug in its class, known as selective phosphodiesterase-4 inhibitors.

INDIANAPOLIS — Patients with Type 1 diabetes using an insulin product made by Eli Lilly can store it in their pumps for longer periods of time, while children using it have additional options, thanks to a labeling change approved Wednesday by the Food and Drug Administration.

SILVER SPRING, Md. — The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus earlier this week recommended that New Nordic US modify or discontinue a wide range of advertising claims for the company’s Mulberry Zuccarin dietary supplement product, including claims made in testimonials.

NEW YORK — Lexington has received clearance from the Food and Drug Administration for marketing the HairMax LaserComb Lux 9 to treat female pattern hair loss, the manufacturer has announced.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the company said Wednesday.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of Syeda (drospirenone and ethinyl estradiol) tablets in the 3-mg/0.03-mg strength.

The drug is a generic version of Bayer HealthCare Pharmaceuticals’ Yasmin. Yasmin and generic versions of the drug had sales of about $365 million during the 12-month period ended in April, according to IMS Health.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.