Third ANDA Approval for Milla Pharmaceuticals Inc. and the 4th U.S. Approval for the Alter Pharma Group.

MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announces U.S. Food and Drug Administration (FDA) has granted approval to the Company's Abbreviated New Drug Application (ANDA) for a 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.

This achievement marks Milla Pharmaceutical’s third ANDA approval within a year and the 4^th ANDA approval of an Alter Pharma product, thereby clearing the path for a 4^th launch of an Alter Pharma product in the U.S. market.

“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.

The Pyridostigmine Bromide Syrup of Milla Pharmaceuticals is expected to launch in the near future.

About Milla Pharmaceuticals

Milla Pharmaceuticals, a wholly-owned subsidiary of the Alter Pharma Group, is engaged in the development, licensing and acquisition of generic prescription drugs for the U.S. market focused on niche injectable and solution products for hospitals and clinics.