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  • Regulatory NewsRegulatory News

    FTC Continues Crackdown on Pay-for-Delay Agreements

    The Federal Trade Commission (FTC) on Monday announced several steps taken against Allergan, its subsidiary Watson Laboratories and Endo Pharmaceuticals to fight pay-for-delay settlements between brand-name and generic drug manufacturers that keep generics from entering the US market. According to a complaint filed in the US District Court of Northern California against Allergan, Watson and Endo, FTC is challenging an anticompetitive reverse-payment agreement between En...
  • Facing Major Repercussions from Bad Inspection, Impax Doubles Down on Compliance

    Pharmaceutical manufacturer Impax Laboratories has announced the formation of a new Compliance Committee it says will be focused on providing oversight for the company's regulated activities after the US Food and Drug Administration (FDA) identified major deficiencies at one of the company's manufacturing facilities. Background: Generic Issues Impax is coming off something of a tumultuous period. On 15 March 2013, FDA announced it would withdraw approval for the compan...
  • Pharmaceutical Company's Regulatory Missteps Tempt Shareholder Legal Action

    • 18 March 2013
    • By
    Generics pharmaceutical manufacturer Impax Laboratories hasn't had an easy last two weeks. On 4 March 2013, it announced that the US Food and Drug Administration (FDA) had, after conducting an inspection at its California Facility, determined that the facility had 12 deficiencies, and issued it a Form 483 . Those deficiencies sent the firm's shares plunging . Then, on 15 March 2013, FDA announced it would withdraw approval for the company's generic equivalent of bupro...
  • FDA Withdraws Approval for Impax's Budeprion after Bioequivalence Concerns Raised

    • 15 March 2013
    • By
    The US Food and Drug Administration (FDA) announced today that it is formally withdrawing the approval of Impax Laboratory's Buproprion Hydrochloride extended release 300mg tablets (Budeprion XL 300 mg), months after asking the company to withdraw the drug after it raised serious concerns regarding the bioequivalence of the generic drug relative to its reference listed drug (RLD). Background In September 2012, FDA announced that it had asked Israel-based manufacturer Te...
  • Facing Criticism, FDA Rethinking Some Therapeutic Equivalence Standards

    US regulators are taking a second look at the way generic drug applications for extended-release generic drug obtain approval several weeks after finding that Teva Pharmaceuticals and Impax Laboratories' Budeprion XL 300mg, supposedly generic to GlaxoSmithKlines' Wellbutrin 300mg, was in fact not therapeutically equivalent. The finding was a setback for the US Food and Drug Administration (FDA), which has fastidiously maintained that nearly all drugs approved through i...