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Assertio-West Therapeutic's hormonal disorder drug rejected by US FDA

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Assertio-West Therapeutic's hormonal disorder drug rejected by US FDA

The U.S. Food and Drug Administration rejected an application filed by Assertio Therapeutics Inc.'s partner West Therapeutic Development LLC, which sought approval of a long-acting version of the drug cosyntropin for a hormonal disorder.

Lake Forest, Ill.-based Assertio said West Therapeutic is seeking approval of the injectable formulation of long-acting cosyntropin for use as a diagnostic drug in screening patients presumed to have adrenocortical insufficiency — an uncommon disorder in which the adrenal glands fail to produce enough cortisol and aldosterone hormones.

In its complete response letter, the FDA determined that certain parameters relating to the drug's effects were not adequately achieved, Assertio said in an Oct. 21 press release.

Assertio President and CEO Arthur Higgins said the two companies will work together to determine how best to address the FDA's letter.