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FDA warns of possible Epipen shortage

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The US Food and Drug Administration is anticipating a shortage of Epipen, Epipen Junior and generic epinephrine auto-injectors.

According to the FDA, manufacturing delays are the reason for what it expects to be a short-term shortage.

EpiPen and EpiPen Jr. are devices made to deliver the lifesaving drug epinephrine during emergency treatment of serious allergic reactions, including anaphylaxis. They are made by Meridian Medical Technologies Inc., a Pfizer company, on behalf on Mylan N.V.

"We understand how important this potentially lifesaving product is to patients, and we are working closely with Mylan to monitor supply levels so patients have access to epinephrine auto injector products," said Steve Danehy, a spokesman for Pfizer.

The American Society of Health-System Pharmacists listed the product on its shortage list. "Supply constraints" prevented adequate stock, according to the society's notice.

In early September, the FDA issued a warning letter to Meridian, which is responsible for the Brentwood, Missouri, facility where EpiPen and EpiPen Jr. are made.

The letter cites "significant violations of current good manufacturing practice (CGMP) requirements for combination products."

In response to the letter, Mylan said that the FDA warning did not "affect Pfizer's ability to manufacture and supply" products from the facility.

 

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