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Regulatory and Washington

  • Once again, Shire seeks FDA approval for Firazyr

    DUBLIN — British drug maker Shire again is trying to win approval for a hereditary angioedema drug that the Food and Drug Administration had previously declined to approve.

    Shire said Monday that it had submitted a response to the "not approvable letter" the FDA sent to German subsidiary Jerini AG in April 2008 for the drug Firazyr (icatibant).

  • Watson seeks regulatory approval for generic Adderall XR

    PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

    British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

  • Life…supplemented kicks off 'Why You Want to Be Well' initiative

    WASHINGTON — Life…supplemented on Thursday announced its fundraising initiative, “Why You Want to Be Well,” for Vitamin Angels for March, and will use Facebook to raise up to $5,000.

  • Protalix receives CRL for Gaucher disease treatment

    KARMIEL, Israel — The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

    The company said the FDA issued a complete response letter for its application for taliglucerase alfa, a treatment for Gaucher disease. The FDA issues a CRL when it has finished reviewing a regulatory application, but questions remain that preclude final approval.

  • Novo Nordisk develops treatment for rarest bleeding disorder, seeks FDA approval

    PRINCETON, N.J. — Novo Nordisk has filed for approval of a treatment for a rare genetic bleeding disorder, the Danish drug maker said Wednesday.

    The company submitted to the Food and Drug Administration its application for recombinant factor XIII compound, for congenital factor XIII deficiency. Current treatments for FXIII deficiency use products derived from human blood plasma, which carries the risk of contamination.

  • Takeda seeks FDA approval for hypertension treatment

    OSAKA, Japan — Drug maker Takeda has filed for regulatory approval of a drug to treat hypertension, the company said Wednesday.

    Takeda announced that it had submitted an application with the Food and Drug Administration for the fixed-dose drug azilsartan medoxomil and chlorthalidone. Azilsartan medoxomil is an angiotensin II receptor blocker, or ARB, that lowers blood pressure by blocking the angiotensin II hormone.

  • Welch promoted to VP scientific and regulatory affairs at NPA

    WASHINGTON — The Natural Products Association on Wednesday announced the promotion of Cara Welch to VP scientific and regulatory affairs.

    “Welch has been a major contributor to achieving the success of both our Natural Seal and GMP certification programs, and she is the perfect choice to lead this department,” stated John Gay, NPA executive director and CEO. “The NPA Natural Seal has been a huge success, with nearly 600 certifications since its launch in 2008.”

  • N.J. governor: Changing Medicaid Rx will help save $41 million

    WASHINGTON — A group representing the nation's pharmacy benefit managers is responding to a proposal made by New Jersey governor Chris Christie that seeks to modernize the state's Medicaid program.

    Christie said the proposed overhaul, which includes managing prescription drug benefits similarly to those in Medicare and private-sector programs, would save the state $41 million, “while still providing vital services,” the governor said.

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