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Regulatory and Washington

  • Makena receives FDA approval

    SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for preventing preterm births.

    The agency announced Friday the approval of Baxter Pharmaceutical Solutions’ Makena (hydroxyprogesterone caproate) injection, for reducing the risk of preterm delivery before 37 weeks of pregnancy in pregnant women with a history of at least one spontaneous preterm birth.

  • Report: Teva seeks approval to market Plan B One-Step for females under 17 years

    NORTH WALES, Pa. — Teva earlier this week announced it had submitted a request to the Food and Drug Administration to allow for the sale of the emergency contraceptive Plan B One-Step to women under the age of 17 years without a prescription, according to published reports.

  • IRS reclassifies breast-feeding as medical expenditure

    WASHINGTON — The Internal Revenue Service on Thursday reversed itself in announcing that breast-feeding supplies qualify as a medical expense.

    The ruling now allows moms who are breast-feeding to purchase all supplies using a flexible spending account. Those without FSAs can deduct the expenses as part of their itemized medical expenditures, including breast-feeding expenses incurred in 2010.

  • FDA approves Quixin generic

    AMITYVILLE, N.Y. — The Food and Drug Administration has approved Hi-Tech Pharmacal’s generic version of a drug for eye infections.

    Hi-Tech announced the approval of levofloxacin ophthalmic solution in the 0.5% strength, a treatment for bacterial conjunctivitis. The company plans to launch next month.

    The drug is a generic version of Vistakon’s Quixin, which had sales of $2 million in 2010, according to IMS Health.

  • Actavis OKed to market generic Protonix

    MORRISTOWN, N.J. — Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.

    The generic drug maker said it would market pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is the generic equivalent of Pfizer's Protonix, which had U.S. sales of approximately $1.6 billion for the 12 months ended Dec. 31, 2010, according to IMS Health.

    Actavis said it would distribute the drug soon.

  • Court: Watson's generic OTC decongestant does not infringe on branded versions

    MORRISTOWN, N.J. — Over-the-counter generic versions of a line of products used to treat congestion do not infringe on the patents covering the branded versions, a federal court ruled Wednesday.

  • NACDS expresses support of The Patients' Freedom to Choose Act of 2011

    ALEXANDRIA, Va. — Companion legislation, which seeks to change a provision in the healthcare-reform law and permit Americans to use their flexible spending accounts and health savings accounts to buy over-the-counter medications without a prescription, has the support of the National Association of Chain Drug Stores.

  • FDA reconsiders safety of OSP use for bowel cleansing as an OTC indication

    SILVER SPRING, Md. — The Food and Drug Administration will propose an amendment to the over-the-counter laxative monograph that sodium phosphate salts are not generally recognized as safe for bowel cleansing.

    A request for public comments will be published in Friday’s Federal Register.

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