ANDA approval of Pyridostigmine Bromide Syrup marks the third ANDA approval within a year for Milla Pharmaceuticals Inc. and the fourth ANDA approval of an Alter Pharma product, thereby clearing the path for a 4th launch of an Alter Pharma product in the U.S. market (after ANDA approvals of Paracetamol IV, Sodium Acetate Injection and Magnesium Sulfate Injection)
The Alter Pharma Group is pleased to announce that its American subsidiary, Milla Pharmaceuticals Inc., has received abbreviated new drug application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its Generic Version of Mestinon® (Pyridostigmine Bromide Syrup) 60 mg/5mL.
Pyridostigmine Bromide Syrup is indicated for symptomatic treatment of myasthenia gravis. Myasthenia gravis is a neuromuscular disorder primarily characterized by muscle weakness and rapid muscle fatigue.
“Once might be luck, twice could still be coincidence, three times for sure is a pattern but the fourth time – especially in such a short period of more or less two years – can only be proof of the fact that we are doing it fast and right, which is an absolute necessity if we want to realize our group’s mission to make affordable, high-quality medicines available to all”, commented Filip Van de Vliet, CEO of the Alter Pharma Group, on this new U.S. addition to the Group’s developmental and regulatory track record.
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