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Re: Double_Bagel post# 214053

Tuesday, 10/03/2017 8:24:59 PM

Tuesday, October 03, 2017 8:24:59 PM

Post# of 257268
Terrible news for MNTA but, fortunately, 180-day exclusivity hasn’t yet been determined; from MYL’s press release:

According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA for Glatiramer Acetate Injection, 40 mg/mL, containing a Paragraph IV certification. Therefore, Mylan and other first filers may be eligible for 180 days of generic drug exclusivity but FDA has not made a formal determination on exclusivity at this time.

Emphasis added.

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