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USFDA Pulls Cadila For Misbranding Saroglitazar, A Diabetes Drug Used In India

  • Post By: YYogesh Joshi
  • 29 Dec 2016

The US drug regulatory agency, U.S. Food and Drug Administration (US FDA) has pulled up Zydus Discovery DMCC, which is a research subsidiary of Cadila Healthcare for misbranding a drug Saroglitazar in a promotional YouTube video. This drug -  branded as Lipaglyn and marketed in India since 2013 - is widely used to treat diabetic dyslipidemia and hypertriglyceridemia

Saroglitazar is a flagship research product of Zydus Cadila.

Broad statement is misleading
The US FDA has, in a December 21 dated letter to the company,  said the company is propagating it as the "world's first" and this "broad statement" is misleading and further directed to cease violating the legal provisions in the US and respond before January 6, 2017. In the same letter, US FDA also noted that from a public health perspective, the presentations and claims are worrying as they include representations in a promotional context regarding the efficacy and safety of an investigational new drug that has not been approved by the FDA.

Drug was approved for India
The US FDA acknowledged that the drug was approved in a particular country (India) but it is not proven to be safe and effective within the meaning of the US FD&C Act and has not been approved as a drug under that authority for any use. The FDA note said "although we acknowledge that saroglitazar is approved for use in another country, the claims and presentations, including the broad statements regarding the drug's approval as the "world's first," furthermore are misleading, suggesting that the drug is approved throughout the world, including in the United States, when that is not the case."

Video does not include any specific information
It added, "The video does not include any specific information regarding Saroglitazar's approval status in the world or any information to indicate that Saroglitazar is an investigational new drug that has not been approved for commercial distribution in the United States."

Taken necessary actions to respond: Says company
To treat fatty liver disease or non-alcoholic steatohepatitis (NASH) apart from diabetic dyslipidemia, the company has been researching on the drug. In a statement to the stock exchanges on Wednesday, Cadila Healthcare clarified that the matter "very specifically relates to an Untitled Letter issued by the US FDA to Zydus Discovery DMCC (a 100% subsidiary of Cadila Healthcare Ltd.) and not a warning letter." "The letter is related to a product promotion of a drug which is not marketed in USA and currently marketed only in India", the company clarified. "We have already taken the necessary actions to respond to this letter," the company stated.