Generic prescription drugs company Milla Pharmaceuticals Inc reported on Tuesday the receipt of the US Food and Drug Administration's (FDA) approval for its Abbreviated New Drug Application (ANDA) for the generic version of Mestinon (Pyridostigmine Bromide Syrup) in 60mg/5ml.
The company added that the Pyridostigmine Bromide Syrup is indicated for symptomatic treatment of myasthenia gravis, a neuromuscular disorder primarily characterized by muscle weakness and rapid muscle fatigue.
In addition, the US FDA's approval marks the company's third ANDA approval within a year and the fourth ANDA approval of an Alter Pharma product, thereby clearing the path for a fourth launch of an Alter Pharma product in the US market.
According to the company, the Pyridostigmine Bromide Syrup of Milla Pharmaceuticals is expected to launch in the near future.
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Milla announces third ANDA approval & fourth US approval for the Alter Pharma Group