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
