Regulatory and Washington

PITTSBURGH The Food and Drug Administration has approved a generic treatment for organ transplant patients.

Mylan announced Tuesday the approval of tacrolimus capsules in the 0.5-mg, 1-mg and 5-mg strengths, and said it plans to launch the drug immediately. The drug is used to prevent rejection of transplanted organs.

WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.

The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.

According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”

ALEXANDRIA, Va. An organization representing the nation's drug stores praised a House subcommittee's legislation that related to the safety of prescription drugs and the security of the drug supply chain.

The National Association of Chain Drug Stores responded Tuesday to a "discussion draft" of drug safety legislation advocated by Reps. John Dingell, D-Mich.; Henry Waxman, D-Calif.; Frank Pallone, D-N.J.; and Bart Stupak, D-Mich., all of whom are members of the House of Representatives' Energy and Commerce Committee.

WOODCLIFF LAKE, N.J. The Food and Drug Administration has accepted for review a regulatory approval application for a patch made by Eisai to treat Alzheimer’s disease, the drug maker said Friday.

The agency will review a patch formulation of Aricept (donepezil hydrochloride), a weekly patch for treating mild, moderate and severe stages of the disease. The drug already is available in tablet form.

WASHINGTON More money is flowing from the federal stimulus coffers to states as the White House continues its push to drive the healthcare system’s massive transformation to a digital and information technology-based platform.

WASHINGTON Generic drugs saved Medicare Part D beneficiaries and the program as a whole $33 billion in 2007, according to a new report by the nonpartisan Congressional Budget Office. The CBO expected another $14 billion in annual savings to accrue as many new generics enter the market through 2012.

The main lobby for pharmacy benefit managers said the report also showed the advantages of pharmacy benefit managers.

SWIFTWATER, Pa. The Food and Drug Administration has accepted a regulatory approval application for a flu vaccine administered in the skin.

Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis, announced Monday that the FDA had accepted its application for Fluzone Intradermal (influenza virus vaccine). The company expects the FDA to take action on the vaccine in the first half of next year.

PHILADELPHIA The Food and Drug Administration did not completely withdraw from the market a drug used to treat a dangerous low blood pressure condition, but merely proposed to do so as a “step in the regulatory process,” according to a document posted on the agency’s website Monday.

The agency said its proposal last month to withdraw approval for Shire’s drug ProAmatine (midodrine) did not represent the actual withdrawal of the drug from the market, while calling for more data on the drug to verify its clinical benefit.