USFDA disapproved a product of Sun Pharma in its present form

Dec 18, 2013 15:49 IST

US Food and Drug Administration (USFDA) in the third week of December 2013 disapproved Sun Pharma Advanced Research Company’s new drug application for an anti-depressant product, in its present form.

As per the Sun Pharma Advanced Research Company, the USFDA has sent a letter to them seeking additional studies related to the efficacy and safety of its Venlafaxine extended release 300 mg tablets. The USFDA can’t approve the application of the drug in its present form.

About Sun Pharma Advanced Research Company

The Sun Pharma Advanced Research Company was formed in 2007 as a pharma research and drug discovery company. It was separated out from the Sun Pharmaceutical Industries Ltd as its active projects in drug discovery and innovation into a new company.  

About US Food and Drug Administration (USFDA)

The US Food and Drug Administration (USFDA) is an agency of the United States Department of Health and Human Services. It is responsible to protect and promote the public health, through the regulation and supervision of different products. As per Section 361 of the Public Health Service Act and associated regulations it enforces other laws, which are not directly related to food or drugs.

President Theodore Roosevelt in 1906 signed Food and Drug Act into a law. The Act was also known as Wiley Act after the name of the Harvey Washington Wiley, the chief advocate, who brought the attention of congress towards public hygiene demonstration. The act was originally named as the Food, Drug and Insecticide Organization and was shortened to Food and Drug Administration (FDA) after some years.

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