Big Flats, NY, May 2, 2016 – X-GEN Pharmaceuticals and Exela Pharma Sciences announced today that Exela Pharma Sciences’ ANDA for Ibuprofen Lysine Injection was approved by the FDA. X-GEN’s Ibuprofen Lysine Injection, under licensing agreement with Exela, is therapeutically equivalent to Recordati Rare Diseases’ NeoProfen® Injection and is the first available generic alternative in the marketplace.
Ibuprofen Lysine is indicated to close a significantly patent ductus arteriosus (PDA), an abnormal opening between the aorta and the pulmonary artery. Ibuprofen Lysine treats premature infants weighing between 500 and 1500 g who are no more than 32 weeks gestational age when usual medical management is ineffective.
The supply of Ibuprofen Lysine has been inconsistent for several years, creating market shortages of this critical drug. Exela’s proven ability for consistent supply and X-GEN’s experience managing its supply chain and distribution networks will ensure consistent availability of this important drug. X-GEN’s President and CEO, Susan Badia, Esq., stated that “X-GEN continues to develop working relationships with our partners throughout the supply chain to find opportunities to improve patient care. Our ability to create unique and meaningful partnerships is a strategic focus for X-GEN, and a key factor allowing us to again be the first generic to market with a product that will make a difference to patients, this time the youngest and most vulnerable.”