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Regulatory and Washington

  • Sun Pharma gets FDA approval for ALS generic

    MUMBAI, India The Food and Drug Administration has approved a generic version of a drug for a devastating muscular disorder.

     

    Sun Pharmaceutical Industries announced Tuesday the approval of riluzole hydrochloride in the 50-mg strength. The tablets are used to treat amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease.

     

     

    The drug is a generic version of Sanofi-Aventis’ Rilutek, which has sales of around $50 million, according to Sun.

     

  • Praising senator, pharmacy groups plead for patient choice in Tricare legislation

    ALEXANDRIA, Va. Speaking with one voice, the nation’s largest chain and independent pharmacy groups gave a thumbs-up Monday to recent efforts by Sen. Frank Lautenberg, D-N.J., to preserve the right of military members and their dependents to obtain their prescriptions through a retail pharmacy without penalty.

  • Retailers urge Congress to reject Chinese currency legislation

    ARLINGTON, Va. As members of Congress move to try and force China to revalue its currency, the renminbi yuan, retailers are weighing in on the issue.

    The Retail Industry Leaders Association, which represents more than 200 retailers, manufacturers and suppliers, asked lawmakers Friday to reject legislation under consideration Friday morning by the House Ways and Means Committee that would pressure China on its currency by imposing tariffs on products imported from there.

     

  • NACDS praises organized retail crime bill

    ALEXANDRIA, Va. A bipartisan legislation that seeks to prevent organized retail crime is being applauded by the chain pharmacy industry.

    The Organized Retail Theft Investigation and Prosecution Act of 2010, introduced by Reps. Bobby Scott, D-Va., and Lamar Smith, R-Texas, would create a specific task force within the Department of Justice to investigate and prosecute instances involving organized retail crime.

  • FDA to allow GSK’s Avandia, with restrictions

    SILVER SPRING, Md. The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes drug made by GlaxoSmithKline.

    The agency said Thursday that it would restrict access to the Type 2 diabetes medication Avandia (rosiglitazone) in response to clinical study data suggesting that its use can increase the risk of heart attacks and strokes.

  • NCPA supports drug disposal bills, makes approval recommendations

    ALEXANDRIA, Va. A group representing the nation's independent pharmacies heralded two pieces of legislation that pertain to the safe disposal of prescription drugs.

    The National Community Pharmacists Association announced its support of legislative efforts made by the House of Representatives and the Senate, which passed their respective drug disposal bills Wednesday and last month. NCPA also added that it was “a giant step forward to allow for controlled substances, which had previously been precluded from any disposal programs, to be included.”

  • NACDS hails passage of three bills to curb medication abuse, diversion

    ALEXANDRIA, Va. Chain pharmacy leaders on Wednesday hailed the passage in the House of Representatives of three industry-backed bills to help remedy prescription medication abuse and diversion.

     

  • Court blocks Apotex's generic Paxil CR

    PITTSBURGH A U.S. District Court has blocked Canadian generic drug maker Apotex from selling generic versions of an antidepressant drug.

     

    Generic drug maker Mylan said Tuesday that it had obtained a temporary restraining order from the U.S. District Court for the District of New Jersey prohibiting Apotex from selling generic versions of the drug Paxil CR (paroxetine hydrochloride), an extended-release formulation of GlaxoSmithKline’s Paxil.

     

     

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