| 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) |
