– Company granted 180-days of exclusivity under FDA Competitive Generic Therapy approval pathway – Milla Pharmaceuticals, 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 Sodium Acetate Injection 2MEQ/mL. Milla Pharmaceuticals was previously granted a Competitive Generic Therapy (CGT) designation for its generic drug by the FDA, which is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also...
News
First Alter Pharma product hits the US market: Sandoz launches generic injectable acetaminophen developed by Milla Pharmaceuticals
Sandoz generic injectable acetaminophen, developed by Milla Pharmaceuticals, immediately available to US patients upon launch On 8 December 2020, Sandoz announced the US launch of its generic injectable acetaminophen (paracetamol IV), available as 100 mL glass vial containing 1,000 mg acetaminophen (10 mg/mL). The generic drug is used in adult and pediatric patients of two years and older to relieve mild to moderate pain and to treat moderate to severe pain in conjunction with opioid analgesics. It can also be used to reduce fever. “At Sandoz, we are continuously growing our injectable medicines portfolio to ensure patients across the US...