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Re: genisi post# 196595

Tuesday, 03/01/2016 3:39:57 PM

Tuesday, March 01, 2016 3:39:57 PM

Post# of 252254
(MYL)—TEVA’s generic EpiPen for US delayed until at least 2017:

http://www.sec.gov/Archives/edgar/data/818686/000119312516485615/d152751d6k.htm

Teva received a complete response letter on February 23, 2016 relating to its epinephrine ANDA in which the FDA identified certain major deficiencies. Teva is evaluating the CRL and intends to submit a response. Due to the major nature of the CRL, Teva expects that its epinephrine product will be significantly delayed and that any launch will not take place before 2017.

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