Responses

  • over 1 year ago

    RE: Quillivant XR being discontinued?

    I believe it is just a shortage in supply; no report as to when it will be resolved.

    https://www.pfizer.com/files/products/Quillivant_XR_OOS_Doctor_Letter_11_7.pdf
      • over 1 year ago
        Hi there,

        I've seen no notice that Quillivant XR is being discontinued.

        Around each year's end, there is typically a shortage of many stimulant medications. The reason is that the DEA (Drug Enforcement Agency) limits the amount of raw materials.

        My understanding is that the limit has not increased in keeping with the rise in ADHD diagnoses. That's a problem.

        Here's the latest info I could find (from the website MPR; the link will not upload here)



        Da Hee Han, PharmD

        January 22, 2018

        Shortage of Two ADHD Medications Due to Manufacturing Delays

        Quillivant XR (methylphenidate HCl ext-rel; Pfizer) oral suspension and Quillichew ER (methylphenidate HCl ext-rel; Pfizer) chewable tablets are currently in shortage, according to the Food and Drug Administration (FDA).

        Quillivant XR, a CNS stimulant, is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older. Due to a manufacturing delay, the following products are currently affected: bottles of 300mg powder (for 60mL suspension), bottles of 600mg powder (for 120mL suspension), bottles of 750mg powder (for 150mL suspension), and bottles of 900mg powder (for 180mL suspension). The next delivery and estimated recovery date is to be determined.
      • 6 months ago
        BRIEF:
        Maker of Pfizer med warned for continued testing issues
        By Jacob Bell
        Published Apr
        The Food and Drug Administration has issued a warning letter to Tris Pharma Inc. for not adequately investigating product failures at its Monmouth Junction, New Jersey, facility.
        During an early 2017 inspection, regulators found that five lots of Quillivant XR, a Pfizer Inc. drug for attention deficit hyperactivity disorder, had failed dissolution testing at the facility between March and November 2016. Rather than determine the root cause of the failures, Tris dismissed out-of-specification results and simply tweaked the testing method "several times."
        Those tweaks meant Tris was "deviating from the method deemed acceptable" for Quillivant XR detailed in the drug's approval application, the FDA argued. What's more, Tris didn't appear to address the problem — the agency noted one lot of drug product still failed under the revised testing method.

        Dive Insight:
        The FDA's letter, dated March 26, extends a lengthy past of production problems at the Monmouth Junction plant. Three prior inspections identified similar issues with Tris' investigations. Meanwhile, drug product that failed dissolution testing was passing through to market.

        The letter also creates a fuller picture of the supply troubles Pfizer has experienced with Quillivant XR. The big pharma recalled multiple lots of the product last year because they didn't meet dissolution specifications.

        By November, it was telling healthcare professionals that a manufacturing issue had caused a shortage of both Quillivant XR (methylphenidate HCl) oral suspension and QuilliChew ER (methylphenidate HCl) chewable tablets.

        Pfizer more recently said it would release 11 lots of Quillivant XR to address the supply shortage, but cautioned that each of the lots might not meet dissolution test specifications either.

        Aside from the Quillivant XR​ debacle, inspectors determined that in the last six months of 2016, Tris received at least two dozen complaints concerning roughly 1,000 bottles of morphine sulfate oral solution seen leaking or under-filled.

        Tris blamed shipping for the damaged bottles, and concluded its investigation even though more complaints were rolling in, according to the FDA.

        "Your response stated you would conduct a 'holistic' investigation to identify a root cause for the leaking bottles. After this investigation, you attributed the leaks to a specific lot of caps that had cracks in their liners and remained in inventory for an extended time without retesting. Your response is inadequate," the FDA wrote, adding that it took eight months before Tris recalled the defective product from the market.

        In typical fashion for repeat violations, the FDA advised Tris to hire a current good manufacturing practice consultant and communicate better with drug application sponsors.

        Recommended Reading:


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  • over 1 year ago

    RE: Quillivant XR being discontinued?

    I was told by my son's doctor in December that it was on backorder. On the 9th of this month she told me she was told they are discontinuing it. I can't find any info either.
  • over 1 year ago

    RE: Quillivant XR being discontinued?

    I just heard from my pharmacy that the Quillivant is manufactured in Puerto Rico and due to storms still back ordered. My son is due for his refill. Any suggestions for alternatives?
      • over 1 year ago
        My pharmacy told me today that Quillivant XR has been discontinued as well. My son's doctor prescribed Quillivant chewables instead. ...haven't checked to see if that is in stock yet.
      • 6 months ago
        website logo
        MENU menu

        BRIEF
        Maker of Pfizer med warned for continued testing issues
        By Jacob Bell
        Published April 12, 2018
        POST
        SHARE
        TWEET
        Dive Brief:
        The Food and Drug Administration has issued a warning letter to Tris Pharma Inc. for not adequately investigating product failures at its Monmouth Junction, New Jersey, facility.
        During an early 2017 inspection, regulators found that five lots of Quillivant XR, a Pfizer Inc. drug for attention deficit hyperactivity disorder, had failed dissolution testing at the facility between March and November 2016. Rather than determine the root cause of the failures, Tris dismissed out-of-specification results and simply tweaked the testing method "several times."
        Those tweaks meant Tris was "deviating from the method deemed acceptable" for Quillivant XR detailed in the drug's approval application, the FDA argued. What's more, Tris didn't appear to address the problem — the agency noted one lot of drug product still failed under the revised testing method.

        Dive Insight:
        The FDA's letter, dated March 26, extends a lengthy past of production problems at the Monmouth Junction plant. Three prior inspections identified similar issues with Tris' investigations. Meanwhile, drug product that failed dissolution testing was passing through to market.

        The letter also creates a fuller picture of the supply troubles Pfizer has experienced with Quillivant XR. The big pharma recalled multiple lots of the product last year because they didn't meet dissolution specifications.

        By November, it was telling healthcare professionals that a manufacturing issue had caused a shortage of both Quillivant XR (methylphenidate HCl) oral suspension and QuilliChew ER (methylphenidate HCl) chewable tablets.

        Pfizer more recently said it would release 11 lots of Quillivant XR to address the supply shortage, but cautioned that each of the lots might not meet dissolution test specifications either.

        Aside from the Quillivant XR​ debacle, inspectors determined that in the last six months of 2016, Tris received at least two dozen complaints concerning roughly 1,000 bottles of morphine sulfate oral solution seen leaking or under-filled.

        Tris blamed shipping for the damaged bottles, and concluded its investigation even though more complaints were rolling in, according to the FDA.

        "Your response stated you would conduct a 'holistic' investigation to identify a root cause for the leaking bottles. After this investigation, you attributed the leaks to a specific lot of caps that had cracks in their liners and remained in inventory for an extended time without retesting. Your response is inadequate," the FDA wrote, adding that it took eight months before Tris recalled the defective product from the market.

        In typical fashion for repeat violations, the FDA advised Tris to hire a current good manufacturing practice consultant and communicate better with drug application sponsors.

        Recommended Reading:
        BioPharma Dive
        Pfizer Hospira plant faces another recalloffsite link
        BioPharma Dive
        CDER in warning letter frenzy as pharma struggles with quality controloffsite link
        Follow Jacob Bell on Twitter

        SHARE
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        Filed Under: Regulatory / Compliance Manufacturing
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  • over 1 year ago
  • over 1 year ago

    RE: Quillivant XR being discontinued?

    If you are still looking for an alternative for Quillivant, their is a new extended release medication called Cotempla XR-ODT that has been suggested for ADHD/ADD treatment. Visit Cotemplaxrodt.com for more information and talk to your doctor for consideration.
  • over 1 year ago

    RE: Quillivant XR being discontinued?

    Hi mom,

    My understanding is that there is only a shortage, not a discontinuation, of Quillivant XR.

    The FDA Drug Shortages site has this information but basically it just says...."nope, don't have it yet and don't know wwen we will."

    https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Methylphenidate%20Hydrochloride%20(QUILLIVANT%20XR)%20for%20Extended-Release%20Oral%20Suspension&st=c

    Perhaps you can call the manufacturer and ask directly.

    800-533-4535 - Pfizer customer line

    Good luck. I know how frustrating it is to find a medicaton that works, only have it to go off the market, be superceded by an inferior generic, etc.

    Gina Pera
  • over 1 year ago

    RE: Quillivant XR being discontinued?

    I was just told that they have discontinued the Quillivant XR
  • over 1 year ago

    RE: Quillivant XR being discontinued?

    This information is NOT correct according to the American Society of Health-System Pharmacists the shortage is temporary

    "Estimated Resupply Dates

    Pfizer has Quillivant XR 5 mg/mL extended-release oral suspension in 60 mL bottles on back order and the company estimates a release date of June 2018."
    https://www.ashp.org/drug-shortages/current-shortages/Drug-Shortage-Detail.aspx?id=373
      • 6 months ago
        website logo
        MENU menu

        BRIEF
        Maker of Pfizer med warned for continued testing issues
        By Jacob Bell
        Published April 12, 2018
        POST
        SHARE
        TWEET
        Dive Brief:
        The Food and Drug Administration has issued a warning letter to Tris Pharma Inc. for not adequately investigating product failures at its Monmouth Junction, New Jersey, facility.
        During an early 2017 inspection, regulators found that five lots of Quillivant XR, a Pfizer Inc. drug for attention deficit hyperactivity disorder, had failed dissolution testing at the facility between March and November 2016. Rather than determine the root cause of the failures, Tris dismissed out-of-specification results and simply tweaked the testing method "several times."
        Those tweaks meant Tris was "deviating from the method deemed acceptable" for Quillivant XR detailed in the drug's approval application, the FDA argued. What's more, Tris didn't appear to address the problem — the agency noted one lot of drug product still failed under the revised testing method.

        Dive Insight:
        The FDA's letter, dated March 26, extends a lengthy past of production problems at the Monmouth Junction plant. Three prior inspections identified similar issues with Tris' investigations. Meanwhile, drug product that failed dissolution testing was passing through to market.

        The letter also creates a fuller picture of the supply troubles Pfizer has experienced with Quillivant XR. The big pharma recalled multiple lots of the product last year because they didn't meet dissolution specifications.

        By November, it was telling healthcare professionals that a manufacturing issue had caused a shortage of both Quillivant XR (methylphenidate HCl) oral suspension and QuilliChew ER (methylphenidate HCl) chewable tablets.

        Pfizer more recently said it would release 11 lots of Quillivant XR to address the supply shortage, but cautioned that each of the lots might not meet dissolution test specifications either.

        Aside from the Quillivant XR​ debacle, inspectors determined that in the last six months of 2016, Tris received at least two dozen complaints concerning roughly 1,000 bottles of morphine sulfate oral solution seen leaking or under-filled.

        Tris blamed shipping for the damaged bottles, and concluded its investigation even though more complaints were rolling in, according to the FDA.

        "Your response stated you would conduct a 'holistic' investigation to identify a root cause for the leaking bottles. After this investigation, you attributed the leaks to a specific lot of caps that had cracks in their liners and remained in inventory for an extended time without retesting. Your response is inadequate," the FDA wrote, adding that it took eight months before Tris recalled the defective product from the market.

        In typical fashion for repeat violations, the FDA advised Tris to hire a current good manufacturing practice consultant and communicate better with drug application sponsors.

        Recommended Reading:
        BioPharma Dive
        Pfizer Hospira plant faces another recalloffsite link
        BioPharma Dive
        CDER in warning letter frenzy as pharma struggles with quality controloffsite link
        Follow Jacob Bell on Twitter

        SHARE
        TWEET
        POST
        EMAIL
        PRINT
        Filed Under: Regulatory / Compliance Manufacturing
        Top image credit: Getty Images
        MOST POPULAR
        SPONSORED
        Rethinking the patient experience with mobile technology
        Ocrevus keeps Roche growing as other pharmas falter
        'Strategic fit' with Bristol-Myers kept Celgene from casting wider net in deal negotiations
        Pharma misses its prescription for growth
        J&J's Erleada has big shoes to fill, and a tough competitor to boot
        STAFF PICKS
        A flashy 2019 start to pharma M&A, but will it last?
        Memorial Sloan Kettering scandal raises questions for pharma's biggest corporate boards
        10 biotechs set to shake up the industry's top ranks
        Red pill or blue? It could be a billion-dollar decision
        7 biopharma trends to watch in 2019
        Get BioPharma Dive in your inbox
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