Will The New Generic EpiPen Be Cheaper? : Shots

The FDA has approved Teva's generic of Mylan's highly successful EpiPen

The FDA has approved Teva's generic of Mylan's highly successful EpiPen

The U.S. Food and Drug Administration announced Thursday it has approved the first generic version of the EpiPen and EpiPen Jr.

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

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

Mylan introduced its own authorized generic form of the EpiPen in late 2016 after the pricing controversy.

"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", he said.

EpiPen is a handheld device that treats life-threatening allergic reactions by automatically injecting a dose of epinephrine, also known as adrenaline.

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The soaring cost of brand name EpiPens, from drug maker Mylan, has led to uproar over the years.

The move paves the way for a lower cost option for patients who suffer from life-threatening allergies.

"Combination products", such as epinephrine auto-injectors that include both a drug and a device, are "more challenging than typical drug products" to develop generic versions, according to the FDA. Dr. Gottlieb has made approval of generics a high priority for the agency, including products commonly referred to as complex generics. "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".

Other epinephrine injectors have been approved before, but they struggled to gain market share against a brand that used lobbying and marketing to establish a virtual monopoly on the market. Although the key ingredient is cheap and the EpiPen itself was first approved in 1987, Mylan began increasing the price of the product, from less than $100 in 2007 for a pack of two injectors to $608 today.

"Any measures that can improve the availability and costs of these medications is a real benefit for our patients", Wood said. There has been "limited availability of EpiPen in certain areas in the USA, including both pharmacy-level supply disruptions and a manufacturer issue", according to FDA spokeswoman Theresa Eisenman.

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