Company Product Description Indication Action/Date
Chiroscience Group plc (UK) Chirocaine Levobupivacaine; chiral version of bupavicaine Long-acting local anesthetic Received approvable letter (3/1)
DUSA Pharmaceuticals Inc. (Canada) Levulan Photodynamic therapy; 20% solution of amino-levulinic acid HCl (topical) Multiple actinic keratoses of the face and scalp Received approvable letter (6/29)
Ergo Science Corp. Ergoset Bromocriptine mesylate Type 2 diabetes Received approvable letter for NDA (10/21)
Novartis AG (Switzerland) Exelon Rivastigmine tartrate capsules Mild-to-moderate Alzheimer's disease Received approvable letter (5/13)