Supply Status Update: June 2019

Our manufacturing partner Meridian Medical Technologies, a Pfizer company, continues to experience manufacturing challenges in the production of 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.

These challenges are expected to result in tighter supplies and greater variability in pharmacy-level access and will potentially continue through the summer months as seasonal demand increases.

Expiration Extension

On June 5, 2019, the U.S. Food and Drug Administration announced the extension of the expiration dates by four months of all lots of EpiPen 0.3 mg Auto-Injectors and its authorized generic version currently on the market in the U.S.

This announcement is based on a careful review of product stability data provided by Pfizer. Our hope is that the expiration extension will help alleviate the shortage situation as Pfizer continues its efforts to increase production and stabilize pharmacy inventories.

The affected lots, which have current expiration dates between February 2019 and October 2020, are listed in the Impacted Product section below and can also be found on FDA’s website. The extension of the expiration dates does not apply to EpiPen Jr (epinephrine injection, USP) 0.15 mg Auto-Injectors and its authorized generic version. Patients must continue to adhere to the manufacturer’s expiry date labeled on EpiPen Jr 0.15 mg and Epinephrine Injection, USP Auto-Injectors 0.15 products.

  • Locating Your Expiration Date

    The expiration date for EpiPen 0.3 mg Auto-Injectors and its authorized generic is located on both the carton and auto-injector itself. Please see example images.

    •  • On the auto-injector, the expiration date is located at the top of the label in black and preceded by the word ‘EXP.’
    •  • On the carton, the expiration date is located on the left flap, which is black in color. You will find the expiration date written in white and preceded by the word ‘EXP.’

    You can confirm if your auto-injector's expiration date has been extended by checking if it matches any of the expiration dates listed in the Impacted Product section below.

    If you have any questions regarding the expiration date of your auto-injector, please call Mylan Customer Relations at 800.796.9526.

  • Impacted Product

    Epinephrine Injection, USP Auto-Injectors 0.3 mg
    NDC 49502-102-02 appears on the box
    NDC 49502-102-01 appears on the individual device within the box

    EpiPen® (epinephrine Injection, USP) 0.3 mg Auto-Injectors
    NDC 49502-500-02 appears on the box
    NDC 49502-500-01 appears on the individual device within the box

    NEW EXTENDED EXPIRATION DATES

    Manufacturer's Original Expiration Date

    New Expiration Date
    Please note: Expiration dates are valid through the last day of the month listed
    Feb 19 Jun 19
    Mar 19 Jul 19
    Apr 19 Aug 19
    Jun 19 Oct 19
    Jul 19 Nov 19
    Aug 19 Dec 19
    Sep 19 Jan 20
    Oct 19 Feb 20
    Nov 19 Mar 20
    Dec 19 (only available in Epinephrine Injection 0.3 mg) Apr 20
    Jan 20 May 20
    Feb 20 (only available in Epinephrine Injection 0.3 mg) Jun 20
    Mar 20 (only available in Epinephrine Injection 0.3 mg) Jul 20
    Apr 20 Aug 20
    May 20 (only available in Epinephrine Injection 0.3 mg) Sep 20
    Jun 20 Oct 20
    Aug 20 (only available in Epinephrine Injection 0.3 mg) Dec 20
    Sept 20 Jan 21
    Oct 20 (only available in Epinephrine Injection 0.3 mg) Feb 21
  • U.S. EpiPen Supply Frequently Asked Questions (FAQ)

    1. What is the current supply status? 

    Mylan’s manufacturing partner Meridian Medical Technologies, a Pfizer company, continues to experience interruptions in the production of EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic version of these strengths. Over the past few months, there has been intermittent supply of EpiPen at wholesalers and pharmacies. Pfizer is working hard to increase production and stabilize supplies, but until this occurs, supplies of EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, will continue to vary from pharmacy to pharmacy and may not always be available.

    2. Who manufactures EpiPen and EpiPen Jr?
     
    Meridian Medical Technologies, a Pfizer company, manufactures EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths.  

    3. What is Mylan’s role? 

    Mylan sells and distributes EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths. Mylan is not the manufacturer.

    4. When will the supply constraints be fully resolved and what are Mylan and Pfizer doing to resolve the situation?

    Mylan is expediting shipments upon receipt from Pfizer. We also are working closely with Pfizer to stay informed of anticipated shipments and are maintaining regular dialogue with health authorities to provide frequent updates on supply status. Pfizer is in communication with Mylan and FDA concerning ways to increase production of EpiPen. Product is routinely shipping and we will continue to provide updates as we have greater certainty around timing for full recovery.

    While Mylan does not have control over the supply situation, our Customer Relations team has been highly successful in assisting patients and caregivers locate a pharmacy where product is available so they may fill their prescription. We encourage individuals who are experiencing difficulty accessing product to call us at 800-796-9526 for assistance in locating alternative pharmacies.

    5. Does the supply constraint affect the EpiPen4Schools® program?

    Over the past year, we have maintained the EpiPen4Schools program to the best of our abilities, despite continued fluctuations in the supply of 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. Our hope is that the expiration extension will help alleviate the shortage situation as Pfizer continues its efforts to increase production. We also are taking the following actions to manage the program under the current shortage situation:

         • Prioritizing filling EpiPen4Schools orders for schools that have expired product on hand. For instance, an order from a school that
       has product expiring June 2019 will be filled before an order from a school that has product expiring November 2019.

         • Pausing on filling requests for additional epinephrine auto-injectors beyond the four free auto-injectors per school in the form of        authorized generic versions of two EpiPen 2-Pak® cartons, two EpiPen Jr 2-Pak® cartons or one 2-Pak of each kind.

    6. Does the expiration extension apply to both strengths?

    No. The stability data does not support an extension of the expiration date to EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors and its authorized generic version. Patients must continue to adhere to the manufacturer’s expiry date labeled on EpiPen Jr® 0.15 mg and Epinephrine Injection, USP Auto-Injectors 0.15 mg products.

    7. Who should I contact if I have additional questions?

    For general inquiries, please contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com. Mylan Customer Relations extended hours of operations are Monday through Friday, 8 a.m. to 7 p.m. ET.

    If you have an inquiry of a medical nature related to EpiPen Auto-Injectors or to report an adverse event, please contact Mylan Medical Information at 1-877-4INFO-RX (1-877-446-3679) or MylanMICC@Mylan.com.

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Need Help?

If you are experiencing difficulty accessing product, please call Mylan's Customer Relations for assistance in locating other pharmacies at 800.796.9526 M-F, 8a-7p ET.

More Important Safety Information

Use EpiPen® (epinephrine injection, USP) 0.3 mg or EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. EpiPen® or EpiPen Jr® should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Hold the leg of young children firmly in place before and during injection to prevent injuries. In case of accidental injection, please seek immediate medical treatment.

Rarely, patients who have used EpiPen® or EpiPen Jr® may develop an infection at the injection site within a few days. Some of these infections can be serious. Call your healthcare professional right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

Tell your healthcare professional about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, high blood pressure or heart problems, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your healthcare professional all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use EpiPen® or EpiPen Jr®.

Common side effects include fast, irregular or “pounding” heartbeat, sweating, nausea or vomiting, breathing problems, paleness, dizziness, weakness, shakiness, headache, feelings of over excitement, nervousness or anxiety. These side effects usually go away quickly if you lie down and rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Indications

EpiPen® and EpiPen Jr®  Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen® and EpiPen Jr® are intended for immediate administration as emergency supportive therapy only. Seek immediate emergency medical help right away.


Please see the full Prescribing Information and Patient Information.

For additional information please contact us at 800-796-9526.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

EpiPen® & EpiPen Jr® (epinephrine injection, USP) Auto-Injectors 0.3/0.15mg

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