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  • Columbia Labs, Watson submit NDA for Prochieve

    LIVINGSTON and PARSIPPANY, N.J. — A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

  • FDA OKs storage option for Kogenate FS

    WAYNE, N.J. — The Food and Drug Administration has approved a new storage option for a hemophilia A treatment made by Bayer HealthCare Pharmaceuticals, the drug maker said.

    Bayer announced that Kogenate FS (antihemophilic factor [recombinant]) now can be stored at room temperature, up to 77 degrees, for up to one year. Previously, it could be stored at room temperature for three months, and most Factor VIII products must be stored in a refrigerator.

  • Watson joins Walgreens on New Life Agency's Fertility Pharmacy Care Card

    RANCHO MIRAGE, Calif. — The New Life Agency has added a prescription progesterone supplement and RESOLVE: the National Fertility Association to the Fertility Pharmacy Care Card.

  • Lamictal XR receives FDA approval as monotherapy

    RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

  • Pozen, AstraZeneca file suit against Dr. Reddy's over generic Vimovo

    CHAPEL HILL, N.C. — A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.

  • AP Pharma announces financing, appoints new executives

    REDWOOD CITY, Calif. — Drug maker AP Pharma has appointed two new executives and may receive financing of up to $4.5 million, the company said Monday.

    AP announced the appointment of John Whelan as president, CEO and director, and Michael Adam as SVP and COO.

  • AstraZeneca's thyroid cancer drug launches

    WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has made the drug vandetanib available to certain thyroid cancer patients.

    The drug maker announced Monday that the drug would be available to patients with medullary thyroid cancer that could not be removed surgically or that had spread to other parts of the body. The Food and Drug Administration approved the drug on April 6, and it is available exclusively through the pharmacy business unit of Biologics Inc., an integrated cancer management company.

  • Menactra approved for use in infants, toddlers

    SILVER SPRING, Md. — The Food and Drug Administration has approved the first vaccine for preventing meningococcal disease in children as young as 9 months old, the agency said.

    The FDA announced the approval of Menactra, made by Sanofi Pasteur, the vaccines arm of French drug maker Sanofi-Aventis. Meningococcal disease is a life-threatening illness caused by Neisseria meningitidis bacteria that infect the bloodstream and the lining surrounding the brain and spinal cord.

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