FDA Policy/General

Zydus Promoting Investigational Drug: OPDP

The CDER Office of Prescription Drug Promotion (OPDP) says that a Zydus Discovery DMCC YouTube video on Lipaglyn (saroglitazar) tablets suggests in a promotional context that the investigational new drug is safe and effective for the purposes for which it is being investigated or otherwise promotes the drug. A 12/21/16 Notice of Violation says there is no U.S. marketing authorization for saroglitazar, which is described in the video as being used to treat patients with diabetic dyslipidemia and hypertriglyceridemia with Type 2 diabetes specifically. “These uses are ones for which a prescription would be needed because they require the supervision of a physician and, therefore, for which adequate directions for lay use cannot be written,” the letter says.

OPDP says that the video’s claims and presentations, some of which also appeared on a convention booth banner, referred to the drug by its proprietary name and made conclusions that it is “indicated for the treatment of diabetic dyslipidemia and hypertriglyceridemia with Type 2 diabetes mellitus,” is “superior” to other molecules, and is not associated with many serious risks that are generally attributed to these other molecules with similar mechanisms of action, when saroglitazar has not been proven to be safe and effective within the meaning of the Federal Food, Drug, and Cosmetic Act and has not been approved as a drug under that authority for any use.

The letter acknowledges the drug’s approval in another country and says that broad statements regarding its approval as the “world’s first” are misleading because they suggest that it is approved throughout the world, including in the U.S., which is not the case.

Zydus was told to immediately stop using violative promotional materials and to respond with a plan for discontinuing use of such materials.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome