Regulatory and Washington

DUBLIN — A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.

Shire said the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of Firazyr (icatibant) for treating acute hereditary angioedema attacks in adults. The committee also voted 11-1 to recommend approval of self-administration of the drug by patients.

HAE is a genetic and potentially fatal immune system disorder that causes swelling of the face and airways and result in airway blockage.

PITTSBURGH — A generic drug made by Mylan for Crohn’s disease does not infringe on the patent for the branded drug, a federal court ruled Thursday.

Mylan said the U.S. District Court for the District of Delaware ruled that Mylan’s regulatory approval application for budesonide capsules in the 3-mg strength does not violate the patent for the branded drug, AstraZeneca’s Entocort EC.

NEW YORK — The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

The FDA issued a complete response letter for Remoxy (oxycodone) extended-release capsules, which Pfizer is developing under a partnership with Pain Therapeutics. Pain Therapeutics originally developed the drug using Durect’s Oradur technology, which is designed to prevent tampering by drug abusers, in collaboration with King Pharmaceuticals. Pfizer took control of development of the drug when it acquired King in February.

CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.

WASHINGTON — The Supreme Court has struck down a law in Vermont designed to encourage generic drug usage by limiting the sharing of information about what branded drugs doctors prescribe, so that drug companies could use it when crafting sales pitches, according to published reports.

MUMBAI, India — Wockhardt has launched three new drugs in the United States over the last three weeks, the Indian generic drug maker said.

Wockhardt announced the Food and Drug Administration's approval and the launch of the company's antibacterial drug levofloxacin, a generic version of Johnson & Johnson’s Levaquin, in the 250-mg, 500-mg and 750-mg strengths.

ALEXANDRIA, Va. — Bipartisan legislation that is aimed to eliminate waste, fraud and abuse in Medicare and Medicaid programs has been introduced to Congress.

Sens. Tom Carper, D-Del., and Tom Coburn, R-Okla., said that the Medicare and Medicaid Fighting Fraud and Abuse to Save Taxpayers’ Dollars Act, which was unveiled Wednesday, would address the aforementioned problems, which often lead to tens of billions of dollars lost to waste and fraud in Medicare and Medicaid every year, the senators said.

HYDERABAD, India — Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

The company said its levofloxacin tablets in the 250-mg, 500-mg and 750-mg strengths have entered the market, following the Food and Drug Administration's approval of Dr. Reddy's abbreviated new drug application. Dr. Reddy's levofloxacin tablets in the 250-mg and 500-mg strengths are available in 50-count bottles, while the 750-mg strength bottle is available in 30-count bottles.