Teva faces delay in US launch for generic version of Mylan's EpiPen

Teva disclosed in a regulatory filing to the Tel Aviv stock exchange on Tuesday that it expects the US launch of its generic version of Mylan's EpiPen (epinephrine) auto-injector to be "significantly delayed" until at least 2017.

The Israeli company noted that the FDA identified "major deficiencies" in its application, issuing the drugmaker a complete response letter on February 23. Teva indicated that it intends to submit a response to the agency.

According to Evercore ISI analyst Umer Raffat, the delay may boost Mylan's 2017 earnings by $0.20 a share, adding "if there is a longer delay, outer year estimates may need more meaningful revision." Raffat noted that analysts had forecast erosion of $200 million in EpiPen sales in 2017.

Sales in Mylan's specialty drug unit, which includes revenue from EpiPen, rose 5 percent to $254.1 million in the fourth quarter. The company said that sales of EpiPen grew following Sanofi's recall of the competing product Auvi-Q (epinephrine) over possible inaccurate dose delivery.

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