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,
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, FDA noted, the claims and presentations are concerning because they include representations in a promotional context regarding 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 autho rity 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, sugges ting that the drug is approved throug hout the world, including in the Uni ted States, when that is not the case“.
“The video does not include any spe cific information regarding Sarogli tazar's approval status in the world or any information to indicate that Sa roglitazar is an investigational new drug that has not been approved for commercial distribution in the Uni ted States,“ it added.
Saroglitazar is a flagship research product of Zydus Cadila. The compa ny has been researching on the drug to treat fatty liver disease or non-alcoho lic steatohepatitis (NASH) apart from diabetic dyslipidemia. In November 2015, Zydus Cadila received approval from the US FDA to conduct phase two studies for dyslipidemia and in June this year, it was cleared for phase two studies in NASH.
In a statement to the stock exchanges on Wednesday , Cadila Healthcare clarified that the matter “very specifically relates to a Untitled Letter issued by the US FDA to Zydus Discovery DMCC (a 100% subsidiary of Cadila Healthcare Ltd) and is not a warning letter“.
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