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First generic EpiPen gets FDA approval

The US Food and Drug Administration has ...

Posted: Aug. 17, 2018 9:38 AM
Updated: Aug. 17, 2018 9:38 AM

The US Food and Drug Administration has approved the first generic competitor to EpiPen and EpiPen Jr. for the emergency treatment of allergic reactions in adults and children.

The company Teva Pharmaceuticals gained approval to market the new generic drug, according to an announcement from the FDA on Thursday.

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Brendan O'Grady, executive vice president who heads North America Commercial at Teva, noted in an emailed statement Thursday that the approval "marks an important step forward in bringing our patients additional prescription medications that have met the FDA's rigorous standards."

"We're applying our full resources to this important launch in the coming months and eager to begin supplying the market," the statement said.

No details are available regarding the cost of the new generic or precisely when it will be available.

'A lower-cost option'

The approval of the generic drug comes after EpiPens were added to the FDA's drug shortage list in May and two years after the maker of EpiPen, pharmaceutical company Mylan, increased costs of its product by more than 400%, leading to public outrage.

The newly approved generic offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen.

"Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector 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 Dr. Scott Gottlieb said in the announcement.

"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," he said.

EpiPen is an auto-injector that delivers epinephrine, more commonly known as adrenaline, a hormone that can help relax muscles in the airways and tighten blood vessels. It can open the airways and reduce swelling during a severe allergic reaction.

Epinephrine injection is used along with emergency medical treatment for life-threatening reactions caused by allergies to insect bites or stings, foods, medications, latex or other causes.

Yet "the path to developing generic drug-device combination products like this one is challenging," Gottlieb said, because combination drugs consist of two parts: the drug, such as epinephrine, and the device, such as the auto-injector.

"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," Gottlieb said.

This effort is part of the administration's overarching aim to "remove barriers to generic development," as outlined in its Drug Competition Action Plan, announced last year.

"We're especially committed to the development of generic copies of complex products," Gottlieb said. "These products can be hard to copy, and therefore sometimes don't face timely generic competition once patents and exclusivities are no longer a block to approval."

He added that "we're advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we're prioritizing review of many complex generic drug applications."

What this means for back-to-school planning

Before the new generic, the only other FDA-approved alternatives to EpiPen were the brand products Auvi-Q and Adrenaclick. The newly approved option made by Teva is the only approved non-brand option.

The American Academy of Allergy, Asthma, and Immunology is "very pleased" with the approval of the new generic, said Dr. Robert Wood, president of the academy and director of pediatric allergy and immunology at Johns Hopkins Medicine in Baltimore.

"Any measures that can improve the availability and costs of these medications is a real benefit for our patients," Wood said.

"There have been recent concerns about shortages of EpiPens, which has been especially an issue as families are refilling prescriptions for back-to-school planning," he said. "We strongly support any measures than can help provide these lifesaving medications in a more cost-effective manner, especially given the concerns about the shortages of EpiPens."

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