Sun Pharma Seeks Recall Of Unapproved Phenobarbital Following Approval Of Its Product
Since FDA has approved Sezaby there is no reason for continued use of unapproved phenobarbital sodium products, firm tells FDA. Sun cites risks to neonates from three excipients in these products. The seizure drug has been marketed since 1940.
You may also be interested in...
FDA is drawing a line in the sand when it comes to unapproved drugs, and that line begins at Sept. 19, 2011.
FDA is encouraging manufacturers of marketed but unapproved drugs to voluntarily submit applications by highlighting the possibility of a de facto exclusivity period for sponsors who receive NDA approval for a drug that other firms are marketing without approval
After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.