• FDA Rebuffs Attempt to Delay Generic Drugs By Scoring Pills

    Pharmaceutical manufacturer Warner Chilcott's attempt to delay generic competition for its Doryx acne pill has been rebuffed by the US Food and Drug Administration (FDA), according a response letter posted by the agency . Warner Chilcott had changed the scores on its Doryx tablets from one score to two scores. The scores are used by physicians and patients to properly split the pills. Warner Chilcott's change, it argued, was substantial enough that any generic manufactu...
  • Hearing on Generic, Biosimilar User Fee Acts Scheduled for 9 February

    The House Energy and Commerce Committee is scheduled to hear testimony from high ranking US Food and Drug Administration and biopharmaceutical industry officials on 9 February. The hearing, Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages , will feature Center for Drug Evaluation and Research Director Dr. Janet Woodcock, Mylan, Inc President Heather Bresch, Generic Pharmaceutical Association Vice President for Reg...