Company Product Description Indication Action/Date
Algos Pharmaceutical Corp. MorphiDex Enhanced opioid analgesic Moderate-to-severe cancer pain Received a not-approvable letter (8/2)
Anika Therapeutics Inc. and Zimmer Inc. (subsidiary of BristolMyers Squibb Co.) Orthovisc High-molecular-weight naturally derived form of hyaluronic acid Osteoarthritis of the knee FDA sent not-approvable letter (2/24)
Aronex Pharmaceuticals Inc. Atragen Liposomal formulation of all trans-retinoic acid Acute promyelocytic leukemia Received not-approvable letter (9/24)
Magainin Pharmaceuticals Inc. Locilex cream (formerly Cytolex) Pexiganan acetate; topical (1% cream); broad-spectrum anti-infective; synthetic magainin (natural hostdefense peptide isolated from frogs) Infection in diabetic foot ulcers NDA deemed not approvable (7/26)
Scios Inc. and Bayer AG (Germany) Natrecor Nesiritide; human B-type natriuretic peptide (BNP; naturally occurring peptide in the heart) Acute episodes of congestive heart failure FDA did not approve NDA; agency said more study needed to define consequences of pharmacodynamic profile, specifically as it relates to the onset of effect and the recovery from hypotension if it occurs (4/27)