Company (Country/Symbol) Product Description Indication Action (Date)
Alliance Pharmaceutical Corp. (ALLP) and Schering AG (Germany) Imagent Ultrasound contrast agent; aqueous dispersion of microbubbles containing mixture of perfluorochemical vapor and a physiological gas To improve ultrasound images of the walls of the heart Received approvable letter for the marketing of Imagent (8/21)
Crescendo Pharmaceuticals Corp. and Alza Corp. (NYSE:AZA) Concerta Extended-release tablet formulation of methylphenidate hydrochloride Attention deficit disorder/attention deficit hyperactivity disorder Received approvable letter (5/18)
Elan Corp. plc (Ireland; NYSE:ELN) and Vernalis Group (UK; LSE:VER; formerly Vanguard Medica Group) Frovatriptan 5HT 1B/1D agonist Acute treatment of migraine Received approvable letter (5/2)
Repligen Corp. (RGEN) and ChiRhoClin Inc. SecretinRepligen Synthetic porcine secretin Pancreatic function diagnostic Received approvable letter (4/28)