FDA gives tentative approval to sincalide for Injection for gallbladder and pancreas disorders.- MAIA Pharmaceuticals.

MAIA Pharmaceuticals announced the Tentative Approval of its sincalide for Injection NDA by the FDA. MAIA's sincalide for Injection is a new and innovative formulation of sincalide that addresses the recurrent shortages of Kinevac as well as Kinevac's shelf-life issues. Recognizing the shortages of Kinevac and the unmet medical need, the FDA granted "Priority Review" to MAIA's NDA. The tentative approval will be eligible for conversion to a final approval subject to the resolution of the current patent litigation between MAIA and Bracco Diagnostics Inc.

As of 2013, there were over 648,000 patients where Kinevac was used to stimulate gallbladder contraction. Until now, Kinevac was the only drug approved by FDA for stimulation of gallbladder contraction and other indications. Over the past 5 years, Kinevac has often been unavailable to patients and prescribers, causing it to be repeatedly listed on the FDA Drug Shortage List. MAIA's Sincalide for Injection is a new and innovative formulation of sincalide that addresses the recurrent shortages of Kinevac as well as Kinevac's shelf-life issues. Recognizing the shortages of Kinevac and the unmet medical need, the FDA granted "Priority Review" to MAIA's NDA.