Assertio Therapeutics Announces FDA Notification of Acceptance for Filing of 505(b)(2) NDA for Long-acting Cosyntropin

Assertio Therapeutics (NASDAQ:ASRT) has announced it has received notice of acceptance for filing from the US Food and Drug Administration (FDA) for its 505(b)(2) New Drug Application for its injectable formulation of long-acting cosyntropin.

As quoted in the press release:

The Company, together with its partner West Therapeutic Development, seeks approval for the use of this product as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency.

“We are pleased to announce another positive milestone in the development of long-acting cosyntropin and in the advancement of our strategy to build a new orphan/specialty business,” said Arthur Higgins, President and Chief Executive Officer of Assertio. “The FDA’s acceptance of our filing positions us one step closer to launching a synthetic long-acting cosyntropin into the U.S. market by early 2020.”

The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of long-acting cosyntropin is set for October 19, 2019. This date reflects a standard 10-month review period and is consistent with management’s expectations for the 505(b)(2) filing.

Click here to read the full press release.