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  • Regulatory NewsRegulatory News

    FDA Wins Court Case to Not Put Vasopressin on Compounding List

    The US Food and Drug Administration (FDA) has won a case in the US District Court for the District of Columbia that hinged on whether an outsourcing facility could continue to compound a bulk substance without a clinical need for that compounded drug. At issue is a drug made by Endo International, known as Vasostrict (vasopressin), which can cost almost $2,000 for 10 milliliters and brought in more than $450 million in 2018 revenues, but which can also be compounded for...
  • Regulatory NewsRegulatory News

    Endo Pulls Opioid From US Market at FDA's Request

    Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request to remove its opioid Opana ER (oxymorphone hydrochloride extended release) from the US market. FDA made the request 9 June “based on its concern that the benefits of the drug may no longer outweigh its risks” after "a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.” As a res...
  • 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...
  • Asking for More Time, FDA Denies Citizen Petition Asking for All Opioids to Be Crush-Resistant

    The US Food and Drug Administration (FDA) has denied a petition submitted by Endo Pharmaceuticals that sought to require manufacturers seeking to market generic versions of its Opana ER (oxymorphone hydrochloride) product to show evidence of similar crush-resistant qualities, saying it needs more time to determine appropriate testing standards-a potential indication that it may be leaning toward such requirements in the future. Background Endo's drug had received appr...
  • Endo Pharmaceuticals Hit With Untitled Warning Letter for Marketing Brochure

    • 02 October 2012
    An untitled letter sent to manufacturer Endo Pharmaceuticals by the US Food and Drug Administration (FDA) accuses the company of promoting Vantas, a subcutaneous implant used as a palliative treatment for advanced prostate cancer, using misleading materials that omit safety information. The letter, sent 25 September to Endo's Associate Director of Regulatory Affairs Mark Klinger, references a consumer-oriented brochure aimed at the spouses of men suffering from adv...
  • Report: Lobbying Pushes Bioavailability Testing Provisions Into House User Fee Bill

    • 30 May 2012
    A well-connected pharmaceutical company has succeeded in inserting a provision into the House's marked-up version of pending user fee legislation to require some fees go toward research to determine whether a generic is as safe and effective as the product to which it is compared, reports The New York Times . The Times reports Endo Pharmaceuticals, soon to be renamed Endo health Solutions, hired a former Congressman and a former House staff member to lobby members of ...
  • Senators Launch Investigation Into 'Dubious Marketing Practices' of Pain Pill Manufacturers

    • 10 May 2012
    Explosive allegations have emerged from two prominent Senators regarding marketing tactics used by a number of pharmaceutical companies, including Purdue Pharma, Endo Pharmaceuticals and Johnson & Johnson, which are alleged to have engaged in "misinformation and dubious marketing practices." The Senators, Max Baucus (D-MT) and Charles Grassley (R-IA), charge the companies were involved in establishing "improper relationships between [the companies] and the organizati...
  • Manufacturing Mix-ups Affect Novartis, Endo Pharmaceuticals

    Swiss pharmaceutical company Novartis Consumer Health Inc. recalled four products yesterday, citing quality concerns that could expose consumers to " foreign tablets, caplets, or capsules ," as well as broken and chipped pills. The product recall affects four popular Novartis-made drugs: Excedrin, NoDoz, Bufferin and GasX. The US Food and Drug Administration's (FDA) statement noted that consumers could be exposed to dangerous doses, unintended ingredients, allergic reac...