Wednesday, August 17, 2022
Aurobindo Pharma Ltd announced that its wholly-owned arm, Eugia Pharma Specialties Ltd, has received final approval from the US health regulator for its generic version of Vasopressin injection.
The injection is indicated to increase blood pressure in adults who suffer from sudden relaxation of blood vessels, according to PTI.
The approval granted by the US Food and Drug Administration (USFDA) is for the manufacturing and marketing of vasopressin injection at a strength of 20 units per milliliter of multiple-dose vials, Aurobindo Pharma said in a regulatory filing.
Click for more on USFDA
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Vasostrict injection, 20 units/ml of Par Sterile Products, LLC (Par), it added.
Vasopressin Injection is indicated to increase blood pressure in adults with vasodilatory shocks, such as due to post-cardiotomy or sepsis, and who remain hypotensive despite fluids and catecholamines.
The product will be launched immediately, the company said.
The approved product has an estimated market size of around USD 606 million for the 12 months ending June 2022, the company said, citing IQVIA data.
Other drugs approval by USFDA
USFDA gives approval for Meclizine HCL Tablets
USFDA gives nod for Prochlorperazine Maleate Tablets
USFDA gives approval generic Labetalol HCL tablets
USFDA gives final approval for Adapalene and Benzoyl Peroxide Topical Gel
USFDA gives final approval for Empagliflozin tablets
USFDA gives final approval to market this anti-inflammatory skin cream
CDSCO Panel gives nod for clinical trial of Elagolix 150 mg for Endometriosis
This drug can fight more than 300 drug-resistant bacteria
20 Blood Banks fined ₹2.3cr for overcharging
Drug recall: Glenmark, Sun, Dr Reddy’s recalled these Drugs
3 strategies to combat Counterfeit drugs and Pharma supply chain threats
USFDA gives approval for Meclizine HCL Tablets
Johnson & Johnson to end global sales of talc-based baby powder
USFDA gives nod for Prochlorperazine Maleate Tablets
Possible carcinogen found in some Diabetes drugs: USFDA
Latest Notifications regarding Pharmaceuticals
https://thehealthmaster.com/2022/08/17/usfda-approves-generic-vasopressin-injection/
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment