The , including anaphylaxis, for adults and children weighing more than 33 pounds, according to an announcement from the agency.
“Today’s approval of the first generic version of the most widely prescribed epinephrine autoinjector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe, and effective generic alternatives once patents and other exclusivities no longer prevent approval,” FDA commissioner Scott Gottlieb, MD, said in the release.
Manufactured by Teva Pharmaceuticals USA, the two strengths of the generic versions are 0.3 mg and 0.15 mg.
The FDA has previously approved other epinephrine autoinjectors, which include brand-name products and so-called “authorized generic” versions of Epi-Pen and Adrenaclick. An authorized generic “is made under the brand name’s existing drug application using the same formulation, process, and manufacturing facilities that are used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product,” according to the FDA statement.
“Complex” generics – those that, as with this generic, include both a drug and a delivery device – face a tougher path to approval because the FDA has to evaluate and approve both components. “We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition, as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines,” Dr. Gottlieb explained.
Side effects of epinephrine autoinjectors include anxiety, restlessness, palpitations, nausea, and weakness; rarely, serious skin and soft-tissue infections after use of epinephrine autoinjectors have been reported.
Find more information about this approval in the FDA press announcement.