Regulatory and Washington

FOSTER CITY, Calif. — Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker's hypertension treatment.

Gilead said the FDA approved a change to the prescribing information for Letairis (ambrisentan 5-mg and 10-mg tablets), the company’s once-daily treatment of pulmonary arterial hypertension.

WASHINGTON — The National Retail Federation said it welcomed the House of Representatives' vote to repeal a provision in last year’s healthcare-reform law that would widely expand the number of IRS 1099 tax forms businesses would be required to file.

NEW YORK — The Manhattan Institute has come up with a novel idea to help New York state slash its healthcare costs by a hefty $350 million by 2020: Expand access to retail health clinics.

Sounds simple enough, right? Think again.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

The FDA approved Banzel (rufinamide) oral suspension for the treatment of seizures in children and adults with Lennox-Gastaut syndrome. The condition, also called LGS, affects 1% to 4% of children with epilepsy.

“This new formulation provides an option for patients who may prefer a liquid or find it difficult to take the medication in tablet form,” Eisai president and CEO Lonnel Coats said.

HUNTSVILLE, Ala. — A subsidiary of Endo Pharmaceuticals has won approval from the Food and Drug Administration for an oral contraceptive.

Qualitest Pharmaceuticals announced Friday the approval of Emoquette (desogestrel and ethinyl estradiol) tablets in the 0.15-mg/0.03-mg strength.

The drug is a generic version of Johnson & Johnson’s Ortho-Cept.

The Obama administration on the official White House website identifies “5 Important Numbers on Health Reform.” These include:

• Zero. The amount consumers would have to pay for premiums, co-insurance or co-payments on any preventive services;

• Fifty. The number of states that now offer insurance options to all people, regardless of any pre-existing conditions;

• One million. The number of doughnut-hole rebate checks mailed to seniors under Part D as of August 2010;

SILVER SPRING, Md. — Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

The FDA said Friday that the drug topiramate could increase the risk for such birth defects as cleft palate and cleft lip when used by expectant mothers. Johnson & Johnson markets the drug under the name Topamax, and it is available in generic form.

With pharmacists across the country now able to administer vaccinations, the Department of Health and Human Services’ plan came at just the right time.