FDA Adds EpiPens to List of Drug Shortages (US News)

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    FDA Adds EpiPens to List of Drug Shortages – By Alexa Lardieri (usnews.com) / May 9 2018

    The FDA says manufacturing delays are causing the shortage of the drug.

    The Food and Drug Administration added the EpiPen to its list of drug shortages Wednesday, citing a disruption with the supply.

    Along with EpiPens, the FDA added generic versions and Adrenaclick autoinjectors to its drug shortage list. All of these medications are used to treat allergic reactions, some of which can be life-threatening.

    According to the FDA Safety and Innovation Act guidelines, the shortages of the EpiPens, its generic versions and Adrenaclick autoinjectors is the result of manufacturing delays. However, the distributor of EpiPens and its generic versions, Mylan, said in a press release that the “product is available and Mylan is currently receiving continual supply from its manufacturing partner.”

    Impax, or Amneal Pharmaceuticals, manufacturers Adrenaclick autoinjectors, which is also experiencing a shortage.

    Mylan says it is expediting shipment of EpiPens to wholesalers and “supply levels may vary across wholesalers and pharmacies.” Although distributed by Mylan, the drug is manufactured by Meridian Medical Technologies, a Pfizer company.

    “A few months ago, Mylan informed the FDA of intermittent supply constraints due to manufacturing delays from Pfizer. Since this time, Mylan and Pfizer have remained in close contact with FDA to provide regular updates on the inventory status,” the release said.

    Pfizer said in a press release it is working to increase production of the medications as quickly as possible.

    “Pfizer takes very seriously the importance of EpiPen to everyone who needs it, and we are working tirelessly to increase production as rapidly as possible,” the release said. “We are currently shipping EpiPen, with production increasing over the last few months and anticipated to continue to increase and stabilize over the coming months.”

    The drug company also asks that customers with a “medically appropriate” supply of unexpired EpiPen be prudent in refilling additional prescriptions during the shortage so others have access to the drug.

    Based on this information, an FDA representative told NBC News, the agency expects the shortage to be short term.

    https://www.usnews.com/news/health-care-news/articles/2018-05-09/fda-adds-epipens-to-list-of-drug-shortages

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