FDA Officially Declares Shortage of EpiPen, Adrenaclick Generic; Auvi-Q Readily Available

The US food and Drug Administration (FDA) has finally declared what what we knew already: There is a shortage of Mylan’s EpiPen and Impax’s Adrenaclick Generic auto-injectors. The FDA added both to its official list of Drug Shortages in the past 24 hours.

Here is the salient information from their website:

Impax Laboratories (New 05/09/2018)

Company Contact Information:
877-99-Impax(46729); option 2
Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector (two pack)(NDC 0115-1695-49) TBD Related to good manufacturing practices
0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector (two pack)(NDC 0115-1694-49) TBD Related to good manufacturing practices
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Mylan Specialty (New 05/09/2018)

Company Contact Information:
800-RXMYLAN (1-800-796- 9526)
Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.3 mg (EpiPen® NDC 49502-500-02) (Authorized Generic NDC 49502-102-02) Available There are intermittent supply constraints due to manufacturing delays from the manufacturing partner, Meridian Medical Technologies, a Pfizer company. Mylan is receiving continual supply from MMT and expediting shipment to wholesalers upon receipt. Supply levels may vary across wholesalers and pharmacies. Patients who are experiencing difficulty accessing product should contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies. Manufacturing delays
0.15 mg (EpiPen® NDC 49502-501-02) (Authorized Generic NDC 49502-101-02) Available There are intermittent supply constraints due to manufacturing delays from the manufacturing partner, Meridian Medical Technologies, a Pfizer company. Mylan is receiving continual supply from MMT and expediting shipment to wholesalers upon receipt. Supply levels may vary across wholesalers and pharmacies. Patients who are experiencing difficulty accessing product should contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies. Manufacturing delays
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The Auvi-Q auto-injector line by Kaleo is not affected by shortages and is readily available per a statement by the company:

Kaléo Confirms AUVI-Q® (epinephrine injection, USP) Availability, May 9, 2018:

Statement from Spencer Williamson, President and CEO of kaléo.

“We understand how critically important it is for those affected by life-threatening allergies to be able to access an epinephrine auto-injector. Kaléo is able to fill, and is filling, all the AUVI-Q® (epinephrine injection, USP) order requests through our Direct Delivery service at www.auvi-q.com. It’s important to note that patients must obtain AUVI-Q through the direct delivery service to ensure delivery to their home or healthcare provider’s office and the best expiration dating for AUVI-Q. Kaléo ensures patients with commercial insurance, or those without commercial or government insurance who have a household income lower than $100,000, can access AUVI-Q for $0 out-of-pocket.”

We are asking our readers to participate in an e-mail campaign to pressure Pfizer, the manufacturer of EpiPen for Mylan, to disclose the source of their manufacturing delays and to provide detailed assurances that the product will be safe to use once supplies are replenished. (The company received a rebuke from the FDA for numerous violations at it’s manufacturing facility in September.)

To participate, simply click this link, sign the e-mail and send.

Note of disclosure: The author’s daughter carries both EpiPen and Auvi-Q auto-injectors, Auvi-Q is currently an advertiser with SnackSafely.com, and Mylan is a frequent advertiser with SnackSafely.com.
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