Anti-coagulant injection issue resolved with USFDA: Dr Reddy's

Drug firm 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 for Injection.

"The company has already addressed all matters raised by the Division of Professional Promotion (DPP), 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 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.

injection is indicated for prophylaxis of (DVT) in patients undergoing hip fracture surgery, hip replacement surgery, knee replacement surgery, or abdominal surgery.

and Brisbane-based Alchemia Ltd had received the approval for injection in July last year.

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Business Standard
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Business Standard

Anti-coagulant injection issue resolved with USFDA: Dr Reddy's

Press Trust of India  |  New Delhi 

Drug firm 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 for Injection.

"The company has already addressed all matters raised by the Division of Professional Promotion (DPP), 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 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.

injection is indicated for prophylaxis of (DVT) in patients undergoing hip fracture surgery, hip replacement surgery, knee replacement surgery, or abdominal surgery.

and Brisbane-based Alchemia Ltd had received the approval for injection in July last year.

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Anti-coagulant injection issue resolved with USFDA: Dr Reddy's

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.

Drug firm 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 for Injection.

"The company has already addressed all matters raised by the Division of Professional Promotion (DPP), 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 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.

injection is indicated for prophylaxis of (DVT) in patients undergoing hip fracture surgery, hip replacement surgery, knee replacement surgery, or abdominal surgery.

and Brisbane-based Alchemia Ltd had received the approval for injection in July last year.

image
Business Standard
177 22

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