Regulatory and Washington

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.

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.

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.

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;

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.

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

As Drug Store News suggested last month, legislation under consideration in Tennessee and Kentucky that would make the popular decongestant pseudoephedrine only available by prescription has, in fact, sparked interest in neighboring states. Arkansas shares a border with Kentucky, where a PSE prescription-only bill was filed in January, and Mississippi, one of two states that already has passed PSE prescription-only legislation.