MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced that it has received FDA approval for its generic version of Precedex®, Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL, and plans to launch in the very near future.
Milla's Generic Dexmedetomidine HydrochlorideReceives Approval in the U.S.
Milla Pharmaceuticals Inc. and the Alter Pharma Group Announce Launch of a Generic Version of Magnesium Sulfate in Water for Injection, in Non-PVC, Single-Patient Use Containers by Their Partner Athenex Pharmaceutical Division (APD)
MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced it has filed its ANDA Application with Paragraph IV Certification on July 20th, 2022 and received a Paragraph IV Acknowledgement Letter and Receipt from FDA on August 31st, 2022. After providing the requisite notice to the NDA holder, the Company reports that the NDA holder has not commenced legal action against the Company within the statutory time frame. It is also worth noting the product is currently listed on FDA’s Drug Shortages List.
Milla Pharma`s Generic Pyridostigmine Bromide Receives Approval in U.S.
Milla Pharmaceuticals's Generic Pyridostigmine Bromide Receives Approval in the U.S.
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.
MINNETONKA, Minn.--(BUSINESS WIRE)--Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced that it has received abbreviated new drug application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its Generic Version of Magnesium Sulfate in Water for Injection, 2 g/50 mL (40 mg/mL), 4 g/100 mL (40 mg/mL), and 4 g/50 mL (80 mg/mL), in Non-PVC, Single-Patient Use Containers (Magnesium Sulfate Injection)