Tuesday, January 03, 2017

PROBLEM OVER PROMOTIONAL YOUTUBE VIDEO - US FDA Pulls Up Cadila Arm for Misbranding Drug

Told to stop violating legal provisions in US; co says it has taken action to respond to letter
Zydus Discovery DMCC, a research subsidiary of Cadila Healthcare, has been pulled up by the US Food and Drug Administration (US FDA) for misbranding Saroglitazar, its drug used in India to treat diabetic dyslipidemia and hypertriglyceridemia, in a promotional YouTube video.
In a December 21 letter to the company, the FDA has said the “broad statements“ made by the company as the “world's first“ is misleading. It directed the company to cease violating the legal provisions in the US and respond before January 6.
From a public health perspective, the FDA noted, the claims and presentations are concerning because they include representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA.
While the US drug regulatory agency acknowledged that the drug was approved in a particular country, it pointed out that 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. Saroglitazar is branded as Lipaglyn and marketed in India since 2013.
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“.
“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,“ it added.
Saroglitazar is a flagship research product of Zydus Cadila. The company has been researching on the drug to treat fatty liver disease or non-alcoholic steatohepatitis (NASH) apart from diabetic dyslipidemia. In November 2015, Zydus Cadila received approval from the US FDA to conduct phase two studies for dyslipidemia .
Cadila Healthcare clarified that the matter “very specifically relates to a Untitled Letter issued by the US FDA to Zydus Discovery DMCC and not a warning letter“.
It added that the letter is related to a product promotion of a drug, which is not marketed in the US and is marketed only in India. “We have already taken the necessary actions to respond to this letter,“ the company said.
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Source: DNA 29th Dec 2016