Drug firm Dr Reddy's Laboratories today said it has resolved all issues raised by a division of US health regulator over its promotional material for an anti-coagulant injection.
On December 22, 2011, Office of Prescription Drug Promotion (OPDP) had issued a letter to the company for changes related to certain promotional material for Fondaparinux Sodium for Injection.
"The company has already addressed all matters raised by the Division of Professional Promotion (DPP), USFDA in the letter issued on January 10, 2012. The DPP informed Dr Reddy's Lab on January 24, 2012 that the matters are now considered closed," Dr Reddy's Lab said in a filing to the BSE.
OPDP through the letter had intimated to the Hyderabad- based drug firm that the company's information on a promotional website for Fondaparinux Sodium Solution for subcutaneous injection was misleading.
"The website is false or misleading because it minimises important risk information associated with the drug in violation of the Federal Food, Drug, and Cosmetic Act," the letter had said.
Fondaparinux sodium injection is indicated for prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery, hip replacement surgery, knee replacement surgery, or abdominal surgery.
Dr Reddy's Laboratories and Brisbane-based Alchemia Ltd had received the USFDA approval for Fondaparinux Sodium injection in July last year.