Regulatory News

  • Bayer lung treatment gains FDA's orphan-drug status

    The FDA gave orphan-drug designation to a powdered form of lung infection medicine ciprofloxacin that is being developed by Bayer HealthCare. Bayer hopes to market the drug to treat Pseudomonas aeruginosa infection in patients with cystic fibrosis.

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  • Debiopharm's 6-month dose of Trelstar obtains FDA approval

    Debiopharm Group and Watson Pharmaceuticals received FDA approval to market a six-month dose of Trelstar for prostate cancer patients. The formulation is expected to be available in May.

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  • FDA approves Sun's generic form of cancer drug Eloxatin

    The FDA approved Sun Pharmaceutical Industries' generic version of Eloxatin, a colon and rectal cancer treatment from Sanofi-Aventis. The approval allowed Sun subsidiary Caraco Pharmaceutical Laboratories to launch a 50- and a 100-milligram formulation of the drug, also known as oxaliplatin.

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  • FDA will look into risk of femur fractures in bisphosphonates

    The FDA will investigate the safety of bisphosphonates, drugs used to treat bone conditions including osteoporosis, in light of reports associating them with atypical subtrochanteric femur fractures. The agency said it did not find a clear connection between the medicines and side effects in data submitted by drug manufacturers.

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  • Montana governor seeks CMS waiver to import drugs from Canada

    Montana Gov. Brian Schweitzer is asking the CMS to allow the state to import pharmaceuticals from Canada to save an estimated $40 million in expenses on Medicaid and other related programs. The agency declined to comment on the issue, saying it has not seen the waiver request.

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  • FDA unit launches workshops to encourage orphan-drug applications

    The FDA's Office of Orphan Products Development is hosting workshops to encourage research into treatments for rare diseases among drug and biotech companies, academic institutes as well as patient advocates. The first seminar was held last month and resulted in 14 submissions for orphan-drug status out of 29 potential sponsors, but Timothy Coté, director of the division, said he hopes to gather more applications during the second workshop in August.

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