FDA Approves First Generic EpiPen

EpiPens have been in short supply for months but the problem became especially acute with back-to-school season

The Food and Drug Administration has approved the first identical alternative to the EpiPen, which is widely used to save children and adults suffering from unsafe allergic reactions. Food and Drug Administration gave approval Thursday for the first generic version of EpiPen, an injection device to treat severe allergic reactions.

The drug is automatically injected into a person's thigh to stop an allergic reaction, the symptoms of which typically include dizziness, vomiting and difficulty breathing. Consumers and lawmakers have been clamoring for a generic version of the EpiPen ever since its manufacturer, Mylan, drastically hiked the price more than 400 percent in less than a decade.

Teva's American depositary receipts rose 7.1 per cent to US$24.06 at 1:02 p.m.in NY.

US -listed shares of Teva jumped 6 percent to $23.88, while those of Mylan were down 1.3 percent at $37.31.

"Today's approval.is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives", FDA Commissioner Scott Gottlieb said in a statement.

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 a year ago.

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Mylan acquired the rights to sell EpiPen in 2007, when it cost about US$57 per shot. In August 2016, Mylan Pharmaceuticals was criticized for raising the price of a two-pack of EpiPens to $600.

Epinephrine alone is already a generic drug and the dose in an auto-injector costs less than a dollar to make.

The FDA has previously approved competitors to Mylan's EpiPen under new drug applications, such as Amedra Pharmaceuticals' Adrenaclick and Kaleo's Auvi-Q.

"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. (Typically, generics can be automatically substituted for the brand name by a pharmacist.) The two rivals haven't sold almost as well as EpiPen without name recognition.

Back in May the FDA also declared a shortage of EpiPens available in the U.S. In addition, Mylan launched an "authorized generic" version of EpiPen in 2016. He pointed out that Mylan now has about 73.5% of the epinephrine market, with its branded EpiPen at approximately 24.7% and its own generic at 48.7%.

Mylan's cap is nonremovable, a fairly recent innovation that prevents users from accidentally pricking themselves or others.

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