Mylan extends expiration date by 4 months to alleviate shortage:
Supply Update - Extended Expiration Dates for current lots of EpiPen® 0.3 mg Auto-Injectors and its Authorized Generic
To address continued shortages of EpiPen®, Pfizer and Mylan are coordinating with FDA to extend the expiration dates by four months of all lots of EpiPen® (epinephrine injection, USP) 0.3 mg Auto- Injectors and its authorized generic version currently on the market in the U.S. after a review of stability data. Patients should have confidence in using the products as Pfizer works to stabilize supply.
This announcement is based on a careful review of product stability data provided by Meridian Medical Technologies, Inc., a subsidiary of Pfizer, that manufactures EpiPen® Auto-Injectors and the authorized generic versions.
The affected lots, which have current expiration dates between February 2019 and October 2020, are listed in a table with their new expiration dates on FDA's website and EpiPen.com/EpiPenSupply. 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.
EpiPen® is a product that requires a highly complex and technical manufacturing and assembly process. Meridian continues to experience manufacturing challenges. 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.
We place great importance on the consistent availability of EpiPen® for everyone who needs it and understand the frustration this ongoing situation continues to pose to patients, caregivers and schools. Our hope is that the expiration extension will help alleviate the 0.3 mg strength shortage situation as Meridian continues its efforts to increase production and stabilize pharmacy inventories.
Mylan, the distributor, is expediting shipments upon receipt from Meridian and continues to encourage patients who are experiencing difficulty accessing product to call its Customer Relations team at 800-796-9526 for assistance in locating alternative pharmacies. Extended hours of operation are Monday through Friday, 8 a.m. to 7 p.m. ET.
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.