Content about 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.

ALEXANDRIA, Va. — The House of Representatives on Thursday passed the bipartisan Small Business Paperwork Mandate Elimination Act of 2011, which repeals the tax-reporting requirement for small businesses included in the healthcare law.

The legislation, introduced by Rep. Dan Lungren, R-Calif., passed in a 314-to-112 vote. The provision, which was part of the Patient Protection and Affordable Care Act , would increase 1099 tax reporting requirements for businesses that purchase goods and services of more than $600.

CHADDS FORD, Pa. — Endo Pharmaceuticals has launched a recently approved testosterone gel for men.

Endo announced Thursday the launch of Fortesta, approved by the Food and Drug Administration for treating low testosterone — or low T — in men, which affects about 14 million men in the United States; around 1.3 million of those men currently are receiving treatment, according to Endo.

ALEXANDRI, Va. — In a letter penned Thursday by the National Association of Chain Drug Stores to Sen. Olympia Snowe, R-Maine, the association stated that while it shares the goal of reducing prescription drug costs, authorizing the reimportation of prescription medications — as sought in S.319, the Pharmaceutical Market Access and Drug Safety Act of 2011 — raises concerns about patient health and safety.

WASHINGTON — The National Retail Federation warned federal transportation officials that transportation costs would increase by up to 20% in some cases if a proposal to limit the number of hours truck drivers spend behind the wheel each day goes into effect.

In addition to dramatically increasing costs, the safety proposal also would make highways a little less safe for the general public by putting more trucks on the road during the most congested hours, the NRF argued.

SILVER SPRING, Md. — The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

The action is part of the agency’s Unapproved Drugs Initiative, which seeks to remove from the market drugs that have not received approval. In many cases, the drugs were marketed before the FDA adopted its current regulatory standards.

SILVER SPRING, Md. — The Food and Drug Administration is warning that long-term use of a class of drugs for gastroesophageal reflux disease may decrease levels of magnesium in the body and increase the risk of such side effects as seizures and heart rhythm problems, according to published reports.

The reports quoted the FDA as saying that in a quarter of cases of proton-pump inhibitors depleting magnesium from the body, use of magnesium supplements did not bring levels back to normal, and use of the drugs had to be stopped.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for chronic obstructive pulmonary disease made by Forest Labs, the agency said Tuesday.

PHILADELPHIA — The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

The drug maker announced the approval of Promacta (eltrombopag) for chronic immune thrombocytopenic purpura, or ITP, in patients who have not responded adequately to other therapies. Chronic ITP results in increased destruction of inadequate production of platelets in the blood, creating an increased risk of bruising and bleeding.

The FDA granted Promacta orphan drug designation in May 2008 and accelerated approval in November 2008.

PITTSBURGH — The Food and Drug Administration has approved a treatment for shingles made by a subsidiary of generic drug maker Mylan.

Mylan announced Monday the approval of Matrix Labs’ gabapentin capsules in the 100-mg, 300-mg and 400-mg strengths. The drug is used to treat postherpetic neuralgia, a painful complication of shingles.

Gabapentin capsules had sales of about $300 million in 2010, according to IMS Health.

WASHINGTON — The National Retail Federation last week responded to the Federal Reserve's proposal to cap debit card swipe fees at 12 cents per transaction.