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Mylan receives FDA approval for generic Prograf
PITTSBURGH The Food and Drug Administration has approved a generic treatment for organ transplant patients.
Mylan announced Tuesday the approval of tacrolimus capsules in the 0.5-mg, 1-mg and 5-mg strengths, and said it plans to launch the drug immediately. The drug is used to prevent rejection of transplanted organs.
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Report: FDA hearing to discuss biosimilar regulations
WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.
The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.
According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”