![]() Please consider the recommendation of more than half of the FDA's Advisory Committee that "OPANA ER remain on the market, but with, additional regulatory restrictions to mitigate the risks of misuse and abuse" as an alternative to initiating a complete withdrawl of OPANA ER from the market. You must consider the effects that your decision will have on these patients and the new health crisis this decision will create. Endo faces 3,100 lawsuits related to sale and marketing of prescription opioids. They will become the victims of an ill advised attempt to stem a crisis they had no part in creating. Patients who use OPANA ER responsibly to alleviate severe, debilitating pain and, who are not helped by other medications, will have no options for pain relief if they are not able to receive OPANA ER. The legal marketing and responsible use of OPANA ER are not the cause of the opioid crisis. ABBVIE INC., Abbott Laboratories, Unimed Pharmaceuticals LLC, and Besins Healthcare, Inc., Petitioners, v. This decision will have devastating consequences for millions of people with chronic pain. ![]() In compliance with the FDA, Endo's decision to remove OPANA ER from the market was based on the FDA's assertion that "the benefits no longer outweigh the risks" given the current opioid epidemic. Sign the petition today to tell Endo to keep Opana ER on the market. To avoid the devastating effects this decision will have on millions of people, Endo must reconsider the recommendation of more than half of the FDA’s Advisory Committee that “OPANA ER remain on the market, but with additional regulatory restrictions to mitigate the risks of misuse and abuse” as an alternative to initiating a complete withdrawal of OPANA ER from the market. We will become the victims of an ill advised attempt to stem a crisis we had no part in creating. If OPANA ER is removed from the market we will have no alternatives for pain relief. We are chronic pain sufferers who, because of the unique way that OPANA ER is metabolized, do not get relief from other medications. THIS DECISION WILL AFFECT MILLIONS OF CHRONIC PAIN PATIENTS WHO, LIKE ME, USE THIS MEDICATION RESPONSIBLY TO ALLEVIATE SEVERE, DEBILITATING PAIN. Resp.) asserting, inter alia, that the Petition is time-barred under 35 U.S.C. IF YOU ARE A CHRONIC PAIN SUFFERER WHO TAKES OPANA ER OR KNOW SOMEONE WHO DOES, IT IS URGENT THAT YOU READ THIS.Īt the request of the FDA, Endo Pharmaceuticals has decided to remove OPANA ER from the market based on the FDA’s assertion that “the benefits no longer outweigh the risks” given the current opioid crisis.Įndo has decided to comply with this request even though it “remains confident” that OPANA ER is safe and effective “when used as intended in appropriate patients.” filed a Preliminary Response (Paper 7) (Prelim. ![]() Demand that Endo Pharmaceuticals keep OPANA ER on the market.
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