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ARTICLE · 12 JANUARY 2017

FDA Objects To Branded Pre-Approval YouTube Video

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We thought our readers might be interested in a recent Untitled Letter that FDA sent to Zydus Discovery DMCC, the US agent/subsidiary of Indian pharmaceutical company Zydus Cadila, . . .

United StatesMedia, Telecoms, IT, Entertainment
Mahnu Davar
Mahnu Davar
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We thought our readers might be interested in a recent Untitled Letter that FDA sent to Zydus Discovery DMCC, the US agent/subsidiary of Indian pharmaceutical company Zydus Cadila, alleging that the company's promotional claims for the product on YouTube, prior to obtaining FDA approval for the drug in the U.S., caused the product to be misbranded under the U.S. Federal Food, Drug, and Cosmetic Act. 

Zydus launched the drug Lipaglyn" (Saroglitazar) in India, which is approved by Indian regulators to treat Type 2 diabetes patients with hypertriglyceridemia or diabetic dyslipidemia, not controlled by statins alone.  Saroglitazar is not, however, approved for any indication in the US. Zydus is currently studying the drug in Phase 2 trials (under an FDA-approved IND) for possible US indications in dyslipidemia and NASH.

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