Palatin: FDA To Review NDA For Bremelanotide; Triggers Milestone Payment

(RTTNews) - Palatin Technologies, Inc. (PTN) announced the U.S. FDA has accepted the bremelanotide New Drug Application for filing. The NDA was filed on March 23, 2018 by AMAG Pharmaceuticals, the company's exclusive North American licensee. The PDUFA goal date for completion of the FDA review of the bremelanotide NDA is March 23, 2019. Bremelanotide is being developed for the treatment of hypoactive sexual desire disorder in premenopausal women.

The FDA's acceptance of the NDA triggers a $20 million milestone payment to Palatin under its license agreement with AMAG Pharmaceuticals, less agreed upon deductions for expenses incurred by AMAG.

In its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting to discuss the application. The company will announce the date of the Advisory Committee meeting when it is scheduled.