FDA may pull digitalis elixirs this month

Digoxin elixirs could vanish o­n June 28. That's the deadline set by the Food & Drug Administration back in 2002. The agency ruled that digoxin makers must obtain formal drug approvals under New Drug Application or Abbreviated New Drug Application procedures for oral formulations. Digoxin tablets had 30 days to meet new approval requirements. Elixirs got two years. At deadline, none of the four elixir suppliers listed in the National Drug Code Directory—Cardinal Health, GlaxoSmithKline, MedPro, and Roxane Laboratories—had received FDA marketing approval yet. An FDA spokeswoman declined to comment o­n the deadline or o­n the agency's plans to enforce the deadline or allow an extension. "Pharmacy and medicine need absolute guidance o­n this issue," Susan Winckler, VP of policy and advocacy for the American Pharmacists Association, told Drug Topics. "We would expect that the agency would provide direct instructions and guidance to avoid problems for patients when the deadline expires. Silence o­n this issue is not helpful."




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