FDA Approves New Epinephrine Product for Children

Officials with the FDA have approved another new epinephrine auto-injector. Admais’ 0.15mg Symjepi is indicated for the emergency treatment of allergic reactions, including anaphylaxis, in children.^1,2

The latest announcement joins a previous approval from the agency for Admais’ 0.3 mg epinephrine auto-injector.¹ In addition, the FDA approved in August the nation’s first truly generic epinephrine auto-injector, in 0.15 mg and 0.3 mg doses, by Teva Pharmaceuticals.³ These products are all expected to become available to the pharmacy market in the near future.^1,3

First Generic Epinephrine Auto-Injector Approved by FDA

The Symjepi 0.15 mg auto-injector, which will be distributed by Sandoz Inc., is indicated for patients weighing between 33 and 65 pounds, and who are determined to be at risk for anaphylaxis. They include individuals with a history of anaphylactic reactions.¹

Carol Lynch, President of Sandoz Inc., said the approval of the 0.15 mg dose provides an affordable alternative to current treatment options for children at risk for anaphylaxis. “We are committed to reimagining their care by bringing this life-saving medicine in a pre-filled epinephrine syringe to the U.S. market at soon as possible,” said Lynch, in a prepared statement.¹

The 0.3 mg Symjepi epinephrine auto-injector is indicated for patients weighing 66 pounds or greater. Both Adamis products provide 2 single-dose injection syringes of epinephrine. The drug is indicated to treat anaphylactic food reactions, such as those caused by nut allergies; insect bites and stings; and exercised-induced anaphylaxis.³

The new approval comes at a time of need for epinephrine. The FDA announced in August an expiration date extension for some epinephrine products, due to a shortage of the drug in the market. The change to recommend use beyond the approved 20-month shelf life was based on stability data provided by pharmaceutical companies that manufacture and market existing epinephrine products, and reviewed by the FDA.⁴

Drug Shortage Prompts Expiration Date Extension for Some Epinephrine Products

References

• Sandoz Inc. announces US FDA approval of pediatric dose of SYMJEPI™ (epinephrine) [news release]. Princeton, NJ; September 27, 2018: Sandoz Inc. https://www.prnewswire.com/news-releases/sandoz-inc-announces-us-fda-approval-of-pediatric-dose-of-symjepi-epinephrine-300720585.html.
• Adamis Pharmaceuticals Receives FDA Approval for Its Lower Dose Symjepi Product [news release]. San Diego, CA; September 27, 2018: Adamis Investor Relations. http://ir.adamispharmaceuticals.com/news-releases/news-release-details/adamis-pharmaceuticals-receives-fda-approval-its-lower-dose.
• Coppock K. First Generic Epinephrine Auto-Injector Approved by FDA. Pharmacy Times online. https://www.pharmacytimes.com/news/first-generic-epinephrine-autoinjector-approved-by-fda. Published August 16, 2018.
• Coppock K. Drug Shortage Prompts Expiration Date Extension for Some Epinephrine Products. Pharmacy Times online. https://www.pharmacytimes.com/news/drug-shortage-prompts-expiration-date-extension-for-some-epinephrine-products. Published August 21, 2018.