Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 mg/50 mL and 400 mg/100 mL Single Dose flexible containers (Bags). The company’s Dexmedetomidine HCI in 0.9% Sodium Chloride Injection is a therapeutic equivalent generic version of Hospira’s Precedex in 0.9% Sodium Chloride Injection. The product will be launched in January 2021.
This is the 79th ANDA to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing injectable & ophthalmic products. The company now has a total of 459 ANDA approvals (431 Final approvals and 28 tentative approvals) from USFDA.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
