Clayton Pharmaceuticals, a thought leader and pioneer in developing innovative pathways to establish bioequivalence for complex generic drug products, announces that they have received FDA approval for Sucralfate Oral Suspension with Competitive Generic Therapy (CGT) designation.
| Approval validates the use of novel pathway for bioequivalence of complex generic drug products, which increases access to affordable versions of life-saving drugs. EXTON, Pa. , April 7, 2022 /PRNewswire/ -- Clayton Pharmaceuticals, a thought leader and pioneer in developing innovative pathways to establish bioequivalence for complex generic drug products, announces that they have 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 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. About Clayton Pharmaceuticals About VistaPharm Ismael Hidalgo
SOURCE Clayton Pharmaceuticals |
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