Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration has approved the first vaccine for preventing meningococcal disease in children as young as 9 months old, the agency said.

The FDA announced the approval of Menactra, made by Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis. Meningococcal disease is a life-threatening illness caused by Neisseria meningitidis bacteria that infect the bloodstream and the lining surrounding the brain and spinal cord.

CHAPEL HILL, N.C. — A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.

PITTSBURGH — Mylan has launched a generic treatment for breast cancer, the drug maker said Monday.

Mylan announced the launch of letrozole tablets in the 2.5-mg strength, an adjuvant treatment for postmenopausal women with hormone receptor-positive early-stage breast cancer.

The drug is the first generic version of Novartis’ Femara, which had sales of about $682 million in 2010, according to IMS Health.

WASHINGTON — Two associations representing dietary supplement companies criticized a British Medical Journal meta-analysis published April 20 that concluded calcium and vitamin D supplementation may increase risk of heart attack and stroke.

ATLANTA — The Centers for Disease Control and Prevention on Thursday announced its CDC Flu App Challenge to identify innovative and creative uses of technology that would help raise awareness of influenza and/or educate consumers on ways to prevent and treat the flu. All told, the challenge will award up to $42,500 in prizes.

The submission period runs through May 27; winners will be announced June 8.

ALBANY, Ore. — In response to a Food and Drug Administration warning letter, Tec Labs announced on Thursday that the company plans to work with the agency regarding its StaphAseptic first-aid antiseptic and pain-relieving gel.

The FDA on Wednesday issued a total of four warning letters, including the one to Tec Labs, to companies that manufacture and market products claiming to prevent infection from methicillin-resistant Staphylococcus aureus bacteria, or MRSA.

ATLANTA — By 2020 or sooner, the entire nation could have laws banning smoking in all indoor areas of private sector worksites, restaurants and bars, a study by the Centers for Disease Control and Prevention released Thursday has found.

The projection is based on the rate at which states have been adopting comprehensive smoke-free laws. In just the past 10 years, 25 states and the District of Columbia have enacted these laws, the CDC reported.

COLUMBUS, Ohio — An Ohio Department of Health study released Wednesday estimated that Ohio’s H1N1 vaccination efforts prevented 64 deaths, 1,400 hospitalizations and 310,402 cases of influenza during the 2009 H1N1 pandemic. The study also estimated that Ohio’s vaccination efforts saved the state $8.4 million in H1N1-related hospitalization costs.