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Granted FDA approval in 2018, this product was made available in hospitals and clinics earlier this year.
The retail launch of Sandoz’ epinephrine (Symjepi) 0.3 mg and 0.15 mg injections was announced today. The launch makes adult and pediatric doses immediately available in local pharmacies across the United States.
Granted FDA approval in 2018, both doses of this product were made available in hospitals and clinics earlier this year.
Sandoz’ 0.3 mg and 0.15 mg injections are indicated for the emergency treatment of allergic reactions including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances and other allergens, as well as idiopathic or exercise-induced anaphylaxis.
“Our collaboration with retail partners will enable patients and their caregivers to conveniently access Symjepi, a cost-effective treatment option with a compact and user-friendly design,” said Carol Lynch, President of Sandoz Inc, a division of Novartis, in a prepared statement.
The 0.3 mg and 0.15 mg injections are intended for immediate administration in patients who weigh approximately 66 pounds or more, and who weigh between 33 and 65 pounds, respectively, who are determined to be at an increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. These epinephrine products are small, single-dose, pre-filled syringes and device combinations that provide an alternative to epinephrine auto-injectors.
Ongoing shortages of epinephrine auto-injectors from several drug manufacturers have been highlighted by the FDA. Pharmacists can ensure patients receive epinephrine medicine alternatives during their first attempt to fill their prescription when doctors prescribe “epinephrine injection” rather than “epinephrine auto-injector,” according to Sandoz.
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Reference
Sandoz extends SYMJEPI™ (epinephrine) Injection launch to US pharmacies to help improve patient access to life-saving medicine [news release]. Princeton, NJ; July 9, 2019: Sandoz website. https://www.us.sandoz.com/news/media-releases/sandoz-extends-symjepi-epinephrine-injection-launch-us-pharmacies-help-improve. Accessed July 9, 2019.