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DewDiligence

10/03/17 8:24 PM

#214054 RE: Double_Bagel #214053

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.