♦ The FDA has extended the expiration dates of all lots of 0.3mg EpiPens® to help with the production delays and shortage. See new expiration dates.
♦ Mylan, distributor of EpiPen®, issued a new statement about the status of their supplies of epinephrine auto-injectors.
♦ Kaléo, maker of AUVI-Q, issued a statement confirming they have an adequate supply of epinephrine auto-injectors.
♦ Walgreens pharmacies will now carry AUVI-Q auto-injectors.
We have heard from members in our community that many are having trouble filling prescriptions for three of the four types of epinephrine auto-injectors:
- EpiPen® and EpiPen Jr® (distributed by Mylan)
- The authorized generic of EpiPen® and EpiPen Jr® (distributed by Mylan)
- Epinephrine injection, USP auto-injector, the authorized generic of Adrenaclick® (distributed by Impax)
This is due to possible shortages at pharmacies. Kids With Food Allergies has confirmed there is no shortage of the drug epinephrine. The shortages at the pharmacies are due to other reasons.
On May 9, 2018, the Food and Drug Administration (FDA) issued a notice about Mylan’s epinephrine auto-injectors: EpiPen®, EpiPen Jr® and their authorized generic versions.
EpiPen® and Its Authorized Generic
According to the FDA’s website, there are some manufacturing delays of the EpiPen auto-injectors made by Pfizer and distributed by Mylan. Supply levels vary depending on the pharmacy and location. It is not a nationwide shortage. Mylan also released a statement about the notice, which you can read below.
Authorized Generic of Adrenaclick®
According to the American Society of Hospital Pharmacists (ASHP), Impax has not given a reason for the shortage of Epinephrine injection, USP auto-injector, the authorized generic of Adrenaclick®. The FDA states the shortage is due to "good manufacturing practices."
From the FDA About Mylan's shortage:
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.
From the FDA About Impax's shortage:
The FDA states shortages are "Related to good manufacturing practices." They give no other information at this time.
What Do I Do If My Pharmacy Doesn’t Have EpiPens® or a Generic?
If your pharmacy is out of EpiPens® or a generic auto-injector, don’t worry. You may have other options. Here are steps to take if your pharmacy can’t fill your prescription:
- Try another pharmacy. The supply issue varies based on suppliers and pharmacies.
- If another pharmacy can’t fill it, ask if they can fill it with a substitute. There are other types of epinephrine auto-injectors available. You may need to request a new prescription from your doctor.
- If your prescription changes to AUVI-Q®, you can fill your prescription through their direct delivery service (which may take around two days to deliver to you).
Note: If you get another brand of auto-injector, remember that they may have different instructions than the EpiPen®.
If you continue to experience challenges in filling your prescriptions, please also let Kids With Food Allergies, a division of the Asthma and Allergy Foundation of America, know. You can post a comment below or contact us at 800-7-ASTHMA.
On May 9, 2018, the U.S. Food and Drug Administration (FDA) posted a supply notification about EpiPen® (epinephrine injection, USP) 0.3 mg and EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, on its website to provide greater transparency and confirm that the product remains available.
As the website posting states, there are intermittent supply constraints; however, product is available and Mylan is currently receiving continual supply from its manufacturing partner Meridian Medical Technologies, a Pfizer company. Mylan is expediting shipment to wholesalers upon receipt, and supply levels may vary across wholesalers and pharmacies.
Mylan and Pfizer take the supply of EpiPen and EpiPen Jr Auto-Injectors very seriously. Pfizer manufactures both the branded and authorized generic versions and Mylan is the distributor.
A few months ago, Mylan informed 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.
Our first priority is to ensure patients with a life-threatening allergy have access to epinephrine auto-injector products. We encourage patients who are experiencing difficulty accessing product to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies. Hours of operation are Monday through Friday, 8 a.m. to 5 p.m. ET.
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