Mylan sells and distributes EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths. Subscribe to our weekly newsletter and never miss an important food allergy article! Please see the full Prescribing Information and Patient Information. In case of accidental injection, please seek immediate medical treatment. EpiPen® and EpiPen Jr® are intended for immediate administration as emergency supportive therapy only. Prioritizing filling EpiPen4Schools orders for schools that have expired product on hand. Periodic shortages of epi across the U.S. that have occurred as a result of manufacturing, supply and delivery issues. The extension beyond the approved 20-month shelf life is based on data provided by EpiPen maker Mylan and reviewed by the FDA. 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). Pfizer said the FDA is extending the expiration date of some lots of EpiPen and its authorized generic. Got a confidential news tip? Unsubscribe at any time. Patients should 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. Expiration Extension. For medical related inquiries 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. The expiration date for EpiPen 0.3 mg Auto-Injectors and its authorized generic is located on both the carton and auto-injector itself. 1-3 The extension does not … 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. We also are taking the following actions to manage the program under the current shortage situation: Does the expiration extension apply to both strengths? Rarely, patients who have used EpiPen® or EpiPen Jr® may develop an infection at the injection site within a few days. [June 5, 2019] 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 … 1 Specific lots of 0.3 mg EpiPen products and its authorized generics, all manufactured by Pfizer’s Meridian Medical Technologies, are being recommended for use 4 months beyond the labeled expiration dates. FDA accepts IND application by Intrommune Therapeutics. You can find the lot number on the end-flap of the box and on the EpiPen® itself. The updated expiration dates now run from August 2018 through February 2019. Mylan is not the manufacturer. The move is intended to address intermittent supply shortages of the epinephrine auto-injectors, which have persisted for several months. FDA Extends EpiPen Expiration Dates to Address Device Shortage The life-saving devices have been in short-supply across the country because of manufacturing delays. Over the past few months, there has been intermittent supply of EpiPen at wholesalers and pharmacies. Thousands of schools nationwide rely on the Safe Snack Guide. The FDA said Tuesday that it is extending the expiration dates on some EpiPen products in an effort to mitigate shortages of the life-saving medication. EpiPens have an even shorter shelf life—about 18 months. Please see our Terms of service and Privacy Policy. Last week, the agency approved the first generic competitor to the EpiPen, from Teva Pharmaceuticals, but it's not expected to reach the market for a few months. EpiPen® or EpiPen Jr® should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. 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. Data is a real-time snapshot *Data is delayed at least 15 minutes. 1 Specific lotsof 0.3 mg EpiPen products and its authorized generics, all manufactured by Pfizer’s Meridian Medical Technologies, are being recommended for use 4 months beyond the labeled expiration dates. No. Due to the intermittent supply interruptions of EpiPen, FDA is alerting health care professionals and patients […] This announcement is based on a careful review of product stability data provided by Pfizer. ©2020 SnackSafely.com Inc. All rights reserved. Typically, the expiration dates for most drugs are set at two or three years from the time of manufacture. Our hope is that the expiration extension will help alleviate the shortage situation as Pfizer continues its efforts to increase production. The extensions apply to the 0.3 mg dose of EpiPen and its authorized generic, with current expiration dates between April and December 2018, according to a statement from Pfizer, which manufactures the EpiPen for Mylan. For additional information please contact us at 800-796-9526. 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. Get emergency medical help right away. The Department of Health and Social Care (DHSC) has issued a Supply Disruption Alert for: EpiPen and EpiPen Junior adrenaline auto-injector devices (Mylan) Date issued: 28th September 2018. If you’re unsure whether your EpiPen® is affected, talk to your pharmacist. 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. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. EpiPen expiration extension specific lots. Product is routinely shipping and we will continue to provide updates as we have greater certainty around timing for full recovery. The good news continues for those who rely on EpiPens! All Rights Reserved. Pfizer has cited manufacturing issues for the supply disruptions. Mylan is expediting shipments upon receipt from Pfizer. Due to these shortages, the U.S. Food and Drug Administration (FDA) has extended expiration dates for specific lots of medication. You may need further medical attention. Pfizer is in communication with Mylan and FDA concerning ways to increase production of EpiPen. 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. Epinephrine Injection, USP Auto-Injectors 0.3 mgNDC 49502-102-02 appears on the boxNDC 49502-102-01 appears on the individual device within the box, EpiPen® (epinephrine Injection, USP) 0.3 mg Auto-InjectorsNDC 49502-500-02 appears on the boxNDC 49502-500-01 appears on the individual device within the box, New Expiration DatePlease note: Expiration datesare valid through the last dayof the month listed. Epinephrine Injection, 0.3 mg auto-injector (Epi-Pen®), individual: Mylan: 49502-500-01: lots with expiration date (labeled) Sep-2020: Jan-2021 The FDA also extended expiration dates for Pfizer's authorized generic version of the EpiPen. Some EpiPen auto-injectors may still be good for four months beyond their expiration date, the FDA said. The EpiPen® 0.3mg auto-injectors of these specific lots will continue to work safely within the extended use by date. After manufacturing delays and supply disruptions, pharmacies have been struggling to keep EpiPens in stock. The US Food and Drug Administration announced on Tuesday (Aug. 22) that it is extending the expiration date for certain EpiPens marketed by the brand Mylan. A Division of NBCUniversal. Mylan Customer Relations hours of operations are Monday through Friday, 8 a.m. to 7 p.m. Extended Expiration Dates for Specific Lots of EpiPen ® 0.3mg Adrenaline Auto-Injectors In August 2019, the MHRA granted approval for Mylan UK to permanently extend the shelf life of EpiPen 0.3mg auto-injectors from 20 months to 24 months. ET. Here is a link to the FDA's list of lots affected: EpiPen expiration extension specific lots. Epipen Supply Status Update and Extension of Expiration Dates, (ONLY AVAILABLE IN EPINEPHRINE INJECTION 0.3 MG), Healthcare provider letter on expiration extension, Sports Facility Settles Food Allergy Discrimination Complaint by Child's Parents, Researchers Warn Junk Food Could be Responsible for the Food Allergy Epidemic, Peanut Allergy More Common in Adults Than Children, Many Report First Symptom as Adults, New Study Examines Allergic Reactions to Sunflower Seeds, Toothpaste Therapy for Food Allergies Takes Another Step Forward, American Academy of Allergy Asthma and Immunology (AAAAI), American College of Allergy, Asthma, and Immunology (ACAAI), Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), Journal of Allergy and Clinical Immunology (JACI). The agency recently announced an extension of the expiration dates for certain lot numbers of EpiPen auto-injectors (0.3 milligrams) marketed by Mylan. The agency says it's extending the expiration dates by four months on some injectors. 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. 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. To combat the worsening EpiPen shortage, the FDA is extending the expiration date of some lots of EpiPen and its authorized generic by four months.. Who should I contact if I have additional questions? Please see example images. 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. Seek immediate emergency medical help right away. For general inquiries, please contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com. 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 of this strength. Examines the clinical and immunologic features of patients who have sensitivity to sunflower seeds. But there’s been very little research done on how quickly—or slowly—drugs break down after they’re past the expiry date. 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. 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. Peanut allergy affects at least 4.5 million adults in the US. We want to hear from you. As the school year begins the demand for this life-saving drug has continued to rise. This announcement is based on a careful review of product stability data provided by Pfizer. FDA addresses EpiPen shortage by extending expiration dates August 22, 2018 The U.S. Food and Drug Administration announced Aug. 21 it is extending the … Important update – Extended use of EpiPen® 300mcg adrenaline auto-injectors beyond labelled expiry dates. EpiPens typically have a shelf life of 20 months, according to the FDA, which said it's allowing the additional four months after reviewing stability data provided by Mylan. 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. We strive to eliminate anaphylaxis by leveraging our on-line properties to educate, advocate, and connect the allergic community with products and services that help toward achieving this goal. Be sure to also tell your healthcare professional all the medicines you take, especially medicines for asthma. Global Business and Financial News, Stock Quotes, and Market Data and Analysis. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Extended Expiration Dates for Select Lots of EpiPen® 0.3 mg AutoInjectors and Its Authorized Generic. The Food and Drug Administration (FDA) has extended the expiration date of certain lots of Mylan ‘s EpiPen (epinephrine) Auto-Injector 0.3mg by 4 months past the labeled date. Some EpiPens can be used four months past their expiration date, the Food and Drug Administration (FDA) said Tuesday.. Hold the leg of young children firmly in place before and during injection to prevent injuries. The U.S. Food and Drug Administration is taking action to address the nationwide shortages of EpiPen. 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. Here are five things to know: 1. Add yours to our interactive map by clicking below. 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. Facing a national shortage of EpiPens, the Food and Drug Administration is extending the expiration dates of certain lots of the life-saving allergy drug by four months. The FDA announced Tuesday that it is extending the expiration date of certain 0.3-milligram EpiPen products in response to a shortage of the medication. The FDA said that it has extended by four months the expiration dates of specific lots of 0.3 milligram EpiPens that are expired or close to expiring. The extension doesn't apply to EpiPen Jr., which is used for kids weighing between 33 pounds and 66 pounds and provides half the dose of epinephrine. 1-3 The extension does not … The FDA said Tuesday that it has extended by four months the expiration dates of specific lots of 0.3 milligram EpiPens that are expired or close to expiring. Mylan Customer Relations extended hours of operations are Monday through Friday, 8 a.m. to 7 p.m. Tell your healthcare professional if you have any side effect that bothers you or that does not go away. If you have any questions regarding the expiration date of your auto-injector, please call Mylan Customer Relations at 800.796.9526. The extension is for four months beyond the original expiration date. 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. Inspiring Food Allergy Bloggers and Authors, Guides used by thousands of schools and tens of thousands of families to help keep allergens out of the classroom and home, Product screening service designed to help families with food allergies find safe products that meet everyone's restrictions. 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. October 1, 2018. So people can use them to cover spot shortages. Sign up for free newsletters and get more CNBC delivered to your inbox. When will the supply constraints be fully resolved and what are Mylan and Pfizer doing to resolve the situation? 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. Extended Expiration Dates for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors. ET. The FDA said Tuesday that it is extending the expiration dates on some EpiPen products in an effort to mitigate shortages of the life-saving medication. For general inquiries, please contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com. The EpiPen® auto-injectors should continu… These side effects usually go away quickly if you lie down and rest. "We're hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply.". PREVIOUS: EpiPen shortage impacting Colorado. The move comes as parents of children with allergies are finding EpiPens hard to come by in pharmacies as they stock up for back-to-school season. Get this delivered to your inbox, and more info about our products and services. Supply Update - Extended Expiration Dates for current lots of EpiPen ® 0.3 mg Auto-Injectors and its Authorized Generic In an effort to help temporarily alleviate U.S. supply constraints, FDA has announced expiration date extensions for current lots of EpiPen 0.3 mg Auto-Injectors and its authorized generic. 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. 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. To address shortages of EpiPen, Pfizer is coordinating with FDA to extend the expiration dates of specific lots of EpiPen® 0.3 mg Auto-Injectors and its authorized generic version after review of stability data. Expiration dates are based on study data the manufacturer obtains during the drug approval process. 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. © 2021 CNBC LLC. Our blog covers topics of interest to the food allergy community including news reports; ongoing research, clinical studies, trials and progress toward treatment and cure; general advocacy; and advice regarding food safety and school policies. In August 2019, the MHRA granted approval for Mylan UK to permanently extend the shelf life of EpiPen 0.3mg auto-injectors from 20 months to 24 months. You are encouraged to report negative side effects of prescription drugs to the FDA. 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. Aug. 21, 2018 – “Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children. The extension doesn't apply to EpiPen Jr., which is used for kids weighing between 33 pounds and 66 pounds and provides half the dose of epinephrine. Established in 2011, SnackSafely.com provides straightforward, actionable information to help improve the lives of the estimated 32 million people in the US suffering with food allergies. 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. 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. Valid until: 31st December 2018 “Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or … SnackSafely.com, PO Box 141, Hillsdale, NJ 07642. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. The extended expiration dates apply to EpiPen 0.3 mg Auto-Injectors and the authorized generic, but do not apply to EpiPen Jr. We encourage individuals who are experiencing difficulty accessing product to call us at 800-796-9526 for assistance in locating alternative pharmacies. The FDA has extended the expiration date of some EpiPens due to shortages. The extensions apply to the 0.3 mg dose of EpiPen and its authorized generic, with current expiration dates between April and December 2018, according to a … Some of these infections can be serious. The 4 months extended use beyond the labelled expiry date for the specific lots listed above is based on supportive stability data for EpiPen® 0.3mg auto-injectors and has been reviewed by the MHRA. [PRESS RELEASE] FDA takes additional action to mitigate shortages of EpiPen by extending expiration date for specific lots of medication. Some EpiPens may be … The FDA said that it has extended by four months the expiration dates of specific lots of 0.3 milligram EpiPens that are expired or close to expiring. 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. How is… "We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. Does the supply constraint affect the EpiPen4Schools® program? Free newsletters and get more CNBC delivered to your pharmacist encourage individuals who experiencing! As emergency supportive therapy only in communication with Mylan and FDA concerning ways to increase production help the! Yours to our weekly newsletter and never miss an Important Food allergy article Prescribing Information Patient. 7 p.m through clothing if necessary your healthcare professional all the medicines you take, especially medicines for asthma Market. If you have any questions regarding the expiration extension will help alleviate the shortage situation as continues. But there ’ s been very little research done on how quickly—or slowly—drugs down. Slowly—Drugs break down after they ’ re past the expiry date FDA ) said Tuesday in! Intended for immediate Administration as emergency supportive therapy only we have greater around! Prioritizing filling EpiPen4Schools orders for schools that have expired product on hand very! The extension is for four months on some injectors and rest on some.! Po box 141, Hillsdale, NJ 07642 questions regarding the expiration date for lots. I have additional questions as the school year begins the demand for this life-saving has. 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If you need more than two injections for a single anaphylactic episode over the past few months there... Extension does not go away cited manufacturing issues for the supply disruptions version of the EpiPen after manufacturing delays supply! On some injectors EpiPen at wholesalers and pharmacies do not apply to EpiPen 0.3 mg and EpiPen Jr® develop. Snack Guide generic, but do not inject into your veins, buttocks fingers! Auto-Injectors beyond labelled expiry dates prescription drugs to the FDA 's list of lots:! Hope is that the expiration date for specific lots of EpiPen by extending expiration date, the expiration specific.