Clayton Pharmaceuticals has received FDA approval for Sucralfate Oral Suspension with Competitive Generic Therapy (CGT) designation.
The approval of this product, through the initial development of twelve different bioassays that tracked the product's postulated clinical interactions using in vitro biology, marks a paradigm shift in how complex generic drug products can be commercialized without the need for expensive, long-drawn, and sometimes non-viable clinical studies. The product was developed in collaboration with VistaPharm (a Vertice company) and Neuheit Pharma Technologies, with testing and analytics support by Absorption Systems and CellPort Software, respectively.
Dr. Sid Bhoopathy, the President and CEO of Clayton Pharmaceuticals, commented "This ANDA approval using well‑designed, scientifically sound in vitro bioassays endorses the use of novel approaches to demonstrate product bioequivalence. It is a proud moment for Clayton and our partners, VistaPharm and Neuheit. We are buoyed by the approval of this product and ready to solve the bioequivalence challenges for the next set of complex products."
Scott Meyers, CEO of Vertice, shared "I am proud that the strong collaboration between our companies has resulted in an FDA approval for Sucralfate Oral Suspension. Congratulations also for the outstanding operational execution that resulted in us quickly receiving CGT designation for this product following FDA approval."
According to IQVIA®, U.S. annual sales for Sucralfate Oral Suspension for the 12 months ended December 2021 were $188.5 million, of which $157.9 million represents generic sales.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!