FDA Gives Adamis OK to Sell Cheaper Alternative to EpiPenThursday, June 15, 2017
Local drugmaker Adamis Pharmaceuticals Corp. just got the OK from regulators to sell its lead product to patients.
The company essentially makes a cheaper alternative to the EpiPen. The company’s epinephrine-filled syringe was approved by the U.S. Food and Drug Administration (FDA) to treat emergency allergic reactions, including anaphylaxis.
The product, called Symjepi, provides two single dose syringes of epinephrine (adrenaline), which is considered the drug of choice for treating allergic reactions to insect stings or bites, allergic reactions to foods, drugs and other allergens, as well as exercise-induced anaphylaxis.
The company’s president and CEO Dennis Carlo said the company is already preparing its second New Drug Application, which will be filed with the FDA for a “junior version” of Symjepi.
“With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market,” Carlo said.
The company expects to launch the product in the second half of 2017.