The U.S. Food and Drug Administration approved the generic versions of the epinephrine auto-injectors EpiPen and EpiPen Jr it said in a statement on Friday.
Those with severe allergic reactions, some of which may be life-threatening, will be relieved to know the auto-injector that can literally save lives will be more affordable.
The generic Pens will be available for both adults and pediatric patients. It is the most-widely prescribed epinephrine auto-injector in the United States.
FDA Commissioner Dr. Scott Gottlieb said in a statement that part of the approval is the FDA’s commitment to advance affordable, safe and effective generic alternatives for patients.
“This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.”
The approval from the FDA will allow Israeli-based drug manufacturer Teva, to compete with Mylan, which has dominated the epinephrine market.
EpiPen was acquired by pharmaceutical company Mylan in 2007. Two years ago, public outrage ensued when the company hiked the cost of the EpiPen by 400 percent.
Those with life-threatening allergies were then forced to shell out $600 for a two-pack of EpiPens which back in 2007 only cost $56. After public scrutiny, Mylan eventually produced a generic version which cut the cost in half.
Gottlieb said, “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.”
Those with life-threatening allergies can be affected by many common materials you may encounter on a day-to-day basis. Allergies can be from insect bites or stings, foods, medication, latex and more.
Anaphylaxis is the outcome of having a life-threatening allergy and occurs in on in 50 Americans. It is the symptom of the reaction to an allergen and can occur within minutes or seconds of being affected.
According to the Mayo Clinic, “Anaphylaxis causes your immune system to release a flood of chemicals that can cause you to go into shock — your blood pressure drops suddenly and your airways narrow, blocking breathing. Signs and symptoms include a rapid, weak pulse; a skin rash; and nausea and vomiting.”
That is the reason there has been an incredible push for affordable versions of epinephrine injectors.
Epinephrine injections are intended for immediate administration, typically into the thigh, to stop the allergic reaction. Though side effects may include anxiety, weakness, dizziness, sweating and more, they are much better than the alternative.