FDA approves Teva’s generic EpiPen after yearslong delay

U.S. regulators cleared the first generic competitor to Mylan’s EpiPen, after a yearslong delay in which many said contributed to the emergency allergy drug’s rapid rise in cost.

Teva Pharmaceuticals received Food in addition to Drug Administration approval for generic versions of both the EpiPen in addition to EpiPen Jr, the agency said in a statement Thursday.

The products are the first competitors cleared by the FDA in which are direct generic copies of the EpiPen in addition to could be substituted for the brand-name product by a pharmacist. additional versions of epinephrine auto-injectors, such as the Adrenaclick in addition to Auvi-Q, are on the market, yet aren’t considered EpiPen generics.

Teva shares rose 6 percent to $37.66 on the news.

“This kind of 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,” FDA Commissioner Scott Gottlieb said inside the statement.

Mylan introduced its own authorized generic form of the EpiPen in late 2016, after an uproar about the branded edition’s cost, which rose more than 400 percent over a decade. The authorized generic, identical to the original except without the brand name, cost half the cost: $300 for a two-pack.

Teva could seek to compete by pricing its generic edition even lower; typically, the item takes multiple generic copies of a medicine entering the market to see prices collapse substantially.

The Israeli company’s application for a generic EpiPen was rejected by the FDA in early 2016, just before the rising cost of Mylan’s product exploded into a major news story heading into back-to-school season, when parents often stock up for kids with allergies.

Though the key ingredient inside the EpiPen, epinephrine, has been available for decades in addition to will be no longer covered by a patent, generic copies of the device have struggled to reach the market because the product will be technically a drug-device combination, in addition to the delivery device proved hard for generic competitors to copy to a degree in which could satisfy regulators.

The FDA issued guidance in November 2017 to try to make the item easier for generic copies of complex medicines like the EpiPen to reach the market, saying some design differences may be approved as substitutable products, as long as those differences don’t affect patients’ ability to use the product the way the item’s intended.

The FDA said Teva’s generic products are anticipated to produce the same clinical effect in addition to develop the same safety profile as the EpiPen in addition to EpiPen Jr. There are smaller differences in design, the regulator said, yet they won’t affect safety or efficacy.

The FDA said Teva’s generic products are anticipated to produce the same clinical effect in addition to develop the same safety profile as the EpiPen in addition to EpiPen Jr. There are smaller differences in design, the regulator said, yet they won’t affect safety or efficacy.

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