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Regulatory and Washington

  • Study: Prescription-only PSE laws have no impact on number of meth labs, meth abusers

    PORTLAND, Ore. — Prescription-only pseudoephedrine regulation has no impact on the methamphetamine trade, according to a Cascade Policy Institute study on the 2005 Oregon law, which restricts access to medicines containing pseudoephedrine.

  • Schumer calls on FDA to investigate inhaler product marketed as supplement

    WASHINGTON — Sen. Charles Schumer on Tuesday announced that the Food and Drug Administration has agreed to conduct a full review of the safety and legality of the new caffeine inhaler AeroShot, distributed by Breathable Foods, which hit stores in New York and Boston this past month.

  • GPhA applauds FDA's action to address shortage of Doxil, methotrexate

    WASHINGTON — The Food and Drug Administration's action to address the ongoing shortage of certain cancer drugs has garnered praise from a group representing the manufacturers and distributors of generic pharmaceuticals.

    The Generic Pharmaceutical Association said it applauded the FDA's action to address the shortage of cancer drugs Doxil (doxorubicin hydrochloride liposome injection) and preservative-free methotrexate. GPhA also added that generic drug manufacturers are tirelessly working with regulators to provide needed supplies of the critical medicines.

  • FDA moves to address cancer drug shortages

    SILVER SPRING, Md. — An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

  • Rep. Slaughter raises concerns about proposed ESI-Medco merger

    WASHINGTON — Rep. Louise Slaughter, D-N.Y., has expressed concerns about the proposed merger between pharmacy benefit managers Express Scripts and Medco in a letter to the Federal Trade Commission.

    The letter, dated Feb. 6, outlines how Slaughter represents a district that contains 34 independent pharmacies — which employ 364 full-time individuals — that fill more than two million prescriptions every year.

  • Nearly $1 billion in damages asserted in lawsuit over GERD drug

    MUMBAI, India — A division of Pfizer is asserting that it incurred nearly $1 billion in damages related to the launch of generic versions of one of its drugs.

    In a lawsuit filed in the U.S. District Court for the District of New Jersey against Sun Pharmaceutical Industries and Teva Pharmaceutical Industries, Wyeth Pharmaceuticals said it estimated that it suffered damages of $960 million from Sun's and Teva's launches of generic versions of the gastroesophageal reflux disease drug Protonix (pantoprazole).

  • McNeil recalls Infant's Tylenol over package design flaw

    FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Friday issued a voluntary recall, at the wholesale and retail levels, of seven lots of Infants' Tylenol oral suspension 1-oz. grape that was distributed nationwide over consumer complaints of the included dosing system.

    McNeil's Infants' Tylenol SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.

  • Oklahoma impact study: Rx-PSE would increase health costs without reducing meth issue

    EDMOND Okla. — According to a report prepared last month by the Economic Impact Group discerning the impact prescription-only pseudoephedrine would have on Oklahoma citizens, prescription-only PSE would result in almost 300,000 additional doctor's office visits at an estimated cost reaching $60 million; $6 million would be directly borne by consumers.

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