Aurobindo Pharma receives USFDA nod for Dexmedetomidine HCL by admin- Wednesday, December 9th, 2020 04:13:39 PM
Aurobindo Pharma has acquired very last approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.Nine% Sodium Chloride Injection, 2 hundred µg/50 mL and four hundred µg/one hundred mL Single Dose bendy packing containers (Bags). Aurobindo’s Dexmedetomidine HCl in zero.9% Sodium Chloride Injection is a healing equal regularly occurring version of Hospira’s Precedex in 0.Nine% Sodium Chloride Injection. The product could be launched in January 2021.
Dexmedetomidine Hydrochloride in zero.Nine% sodium chloride injection is a exceptionally selective alpha2 -adrenergic agonist indicated for a) sedation f to begin with intubated and robotically ventilated sufferers at some point of remedy in an in depth care putting; b) sedation of non-intubated sufferers prior to and/or throughout surgical and other methods. The authorised product has an envisioned market length of US$ 228 million for the three hundred and sixty five days ending October 2020 in step with IQVIA.
This is the 79th ANDA to be authorized out of Unit IV method facility in Hyderabad, India used for manufacturing injectable & ophthalmic merchandise. Aurobindo now has a complete of 459 ANDA approvals (431 Final approvals and 28 tentative approvals) from USFDA.