On the heels of great criticism, pharmaceutical company giant Mylan made sure to announce it expects for the generic release of its popular brand-name EpiPen product to eventually account for at least 85 percent of all auto-injector anti-allergic reaction injector devices.
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The Israeli drugmaker, in a webcast overview of its generics medicines business, said it plans to meet with the U.S. Food and Drug Administration about potentially re-submitting Teva’s U.S. marketing application for the device.
Teva’s application for its epinephrine injector has been in question since February, when the FDA cited “major deficiencies” with the device. The company’s strengths can be seen in multiple areas, such as its revenue growth, largely solid financial position with reasonable debt levels by most measures and expanding profit margins.
EpiPen’s list price has soared from less than $100 when Mylan acquired it in 2007, to more than $600 now, sparking outrage from patients, consumers and politicians.
EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016.
Last week the US Senate investigations panel launched a “preliminary inquiry” into the company’s pricing of the EpiPen.
“There isn’t much discussion of what analyses went into the price-setting in response to my question”, Grassley said.
Grassley replied that he appreciated receiving the information provided by Mylan, but called it an incomplete response that would not satisfy constituents upset about the EpiPen price increases. “It doesn’t provide the full picture that I requested, and it doesn’t answer all of my questions”, Grassley said in prepared remarks.
It’s a delicate issue for some senators because Mylan CEO Heather Bresch is the daughter of one of their colleagues, Democratic Sen. He added that it is still unclear how many patients will benefit from Mylan’s expanded assistance programme. Since then, shares have slowly but steadily declined.
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Material from Reuters was used in this report.
