Regulatory and Washington

WASHINGTON — A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

U.S. District Court Judge John D. Bates said in an opinion filed on Dec. 27, that the FDA did not act “capriciously” when it denied Mylan exclusivity to market its version of Diovan. Bates also said Mylan did not show it suffered “irreparable harm” as a result.

WASHINGTON — The Consumer Healthcare Products Association last week applauded Ohio Gov. John Kasich for signing into law House Bill 334, an anti-methamphetamine bill authored by Reps. Terry Johnson, R-Portsmouth, and Danny Bupb, R-West Union. With the new law, Ohio now becomes the 25th state to adopt real-time, stop-sale technology known as the National Precursor Log Exchange.

BETHESDA, Md. — The National Institute on Drug Abuse last week released the 2012 Monitoring the Future survey, finding that 5.6% of high school seniors abused over-the-counter cough and cold medicines containing dextromethorphan, a rate that has held relatively steady over the past five years. Abuse of DXM products was reported to be 3% among eighth graders and 4.7% among tenth graders, bringing the overall average to under 5%.

CAMBRIDGE, Mass. — The Food and Drug Administration on Monday approved Aegerion Pharmaceuticals' cholesterol drug, Juxtapid.

The drug — an alternative treatment for patients who have a genetic predisposition to high cholesterol — will carry a boxed warning, the strongest level of FDA warning. Juxtapid will be available only through a restricted program due to risk of liver damage.

SILVER SPRING, Md. — The Food and Drug Administration has approved a common flu drug for use in children as young as 2 weeks old, the agency said Friday.

The FDA announced the new approval for Genentech's Tamiflu (oseltamivir). The agency said that while patients ages 1 year and older can receive the same dosage, those younger than 1 year must be dosed based on their exact weight.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug to treat a condition that affects people who have had their intestines partially or completely removed, the agency said Friday.

The FDA announced the approval of NPS Pharmaceuticals' Gattex (teduglutide) for daily injection in adults with short bowel syndrome who need additional nutrition from intravenous feeding. SBS results from partial or complete surgical removal of the small or large intestine, which can lead to poor absorption of fluids and nutrients from food.

CHADDS FORD, Pa. — A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

The U.S. District Court for the District of Columbia dismissed a case filed by Endo subsidiary Endo Pharmaceuticals against the Food and Drug Administration, in which the company had argued that the FDA failed meet a legal obligation to determine whether the original formulation of Opana ER (oxymorphone) extended-release tablets was withdrawn from the market for safety reasons.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for reducing the severity of chickenpox symptoms, the agency said Friday.

The FDA announced the approval of Cangene Corp.'s Varizig (varicella zoster immune globulin [human]) for varicella zoster, the virus that causes chickenpox. The FDA said Varizig was the only FDA-approved immune globulin for the virus after exposure.