APP Pharmaceuticals, Praised For Easing Drug Shortages, Gets Manufacturing Warning Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
APP is singled out for helping alleviate the shortage of the cancer drug methotrexate at the same time the company’s manufacturing plant in Grand Island, N.Y. is cited for numerous cGMP violations.
You may also be interested in...
Contamination Issues Drove Drug Recalls to Record Levels in 2011
How contamination, sterility assurance, OOS and other issues caused drug recalls to spike again last year. What happened at Aidapak, H&P, Ben Venue, Hospira, Teva and other manufacturers to set a new record.
Drug Shortages Endgame: FDA Goes On Offensive As Legislative Plot Thickens
FDA press conference on alleviating shortages shows how the agency works with industry to advance legislation that firms may not be particularly fond of themselves. But the agency still seems to face an uphill legislative battle.
FDA Drug Shortage Strategy: Enforcement Discretion, Patient Public Relations
Rapid approval of a new, preservative-free generic methotrexate and permission to import an unapproved version of doxorubicin touted at press conference as FDA emphasizes the success of administrative efforts.