FDA approves Trulance from Synergy Pharmaceuticals
The Food and Drug Administration has approved Synergy Pharmaceuticals’s Trulance (plecanatide), the company and agency announced Thursday. The drug is indicated to treat adults with chronic idiopathic constipation. It’s the first drug designed to replicate the function of the gastrointestinal peptide uroguanylin.
“We are thrilled with the approval of Trulance because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and their healthcare providers manage this condition,” Synergy Pharmaceuticals chairman and CEO Gary Jacobs said. “I am confident that we truly have the right team with the right strategic vision and the right launch plan to successfully bring Trulance into this large but underserved market.”
The company said Trulance would be available later this quarter.
FDA approves Aurobindo’s Geodon generic
SILVER SPRING, Md. — The Food and Drug Administration has approved Aurobindo’s generic of Geodon (ziprasidone HCl) capsules, the company announced Wednesday. The drug is indicated to treat schizophrenia.
Aurobindo’s generic will be available in 20-, 40-, 60- and 80-mg dosage strengths. The drug has an estimated market size of $117 million for the 12 months ended November 2016, according to QuintilesIMS.
FDA approves Allergan’s Rhofade cream
SILVER SPRING, Md. — The Food and Drug Administration has approved Allergan’s Rhofade (oxymetazoline hydrochloride) cream, the company announced Thursday. The cream is indicated to treat persistent facial redness from rosacea in adults.
"The FDA approval of Rhofade exemplifies Allergan's commitment to continuing to address unmet patient needs through innovation in medical dermatology,” Allergan chief R&D officer David Nicholson said. "The FDA approval of Rhofade represents a new prescription treatment that can effectively help physicians and their patients manage this condition."
The National Rosacea Society estimates that some 16 million Americans are affected by rosacea. The company expects the drug to be available for commercial supply in May.
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