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Synergy Pharma's Trulance Gets FDA Approval, CEO 'Truly Thrilled'

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Synergy Pharma's Trulance Gets FDA Approval, CEO 'Truly Thrilled'

The U.S. Food and Drug Administration said it approved Synergy Pharmaceuticals Inc's (NASDAQ: SGYP) plecanatide, branded as Trulance, for the treatment of chronic idiopathic constipation (CIC). This approval marks the company’s first.

Trulance is a one-tablet-a-day drug used to treat a form of gastrointestinal disorder that make patients have difficult and infrequent bowel movements. The drug is expected to generate peak sales of $348.8 million by 2021, Thomson Reuters has estimated.

Benzinga reached out to Synergy Pharma’s CEO, Gary Jacob, who provided this statement:

“We are truly thrilled with this approval because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and healthcare providers manage this condition.”

Synergy said it has plans to file a supplemental New Drug Application (NDA) for Trulance over the course of the current quarter seeking approval for the treatment of irritable bowel syndrome with constipation (IBS-C).

The stock initially fell over a $1 per share in the after-hours session and traded recently at $6.35, down about $0.06 from the close.

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