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Regulatory and Washington

  • Cumberland gets FDA OK for Acetadote formulation

    NASHVILLE, Tenn. — The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

    Cumberland Pharmaceuticals announced Thursday that the agency had approved a version of Acetadote (acetylcysteine) injection that does not contain preservatives or stabilization and chelating agents, and will replace the currently marketed version. The drug originally was approved in 2004.

  • FDA warns consumers of liver injury risk when taking Multaq

    SILVER SPRING, Md. — The Food and Drug Administration and drug maker Sanofi-Aventis are warning healthcare professionals and patients about the possibility of severe liver injury in patients taking a Sanofi heart drug.

  • Kentucky introduces PSE Rx legislation

    FRANKFORT, Ky. — The battle for the prescription status of methamphetamine precursor/popular cough-cold ingredient pseudoephedrine now is heating up in Kentucky, just a few days following a Nevada news report that suggested the state will be considering PSE prescription-only requirements just as soon as a bill is introduced by Nevada Sen. Sheila Leslie, D-Reno.

  • McNeil issues recall at wholesaler level

    FORT WASHINGTON, Pa. — In consultation with the Food and Drug Administration, McNeil Consumer Healthcare on Friday voluntarily recalled certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain and Tylenol upper respiratory products, as well as certain lots of Benadryl, Sudafed PE and Sinutab products at the wholesale level.

  • K-V: FDA will approve Gestiva by PDUFA date

    ST. LOUIS — K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

    K-V, which acquired the injected drug Gestiva (hydroxyprogesterone caproate) from Hologic in 2008, said Hologic originally had been told the FDA would take action Thursday.

    K-V said it was confident the drug would receive approval and that the FDA would take action on or before the new PDUFA date.

  • Report: Nevada looks to push PSE Rx legislation

    LAS VEGAS — Nevada Sen. Sheila Leslie, D-Reno, is working with Carson City district attorney Neil Rombardo on introducing a bill to require a prescription for pseudoephedrine as a tool to cut down on illicit methamphetamine production, the Las Vegas Review-Journal reported Wednesday evening.

  • FDA limits amount of acetaminophen in prescription drugs

    SILVER SPRING, Md. — The Food and Drug Administration is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity, the agency said Thursday.

  • NCPA sends letter to House committee chairman on ways to help pharmacy, patients

    ALEXANDRIA, Va. — The independent pharmacy lobby has issued a letter to the House Committee on Oversight and Government Reform chairman, Rep. Darrell Issa, R-Calif., with insight on how certain current or proposed federal regulations can burden pharmacies and their patients.

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