Will submit two NDAs over the next 12 months, including the oral antibiotic Unasyn (sultamicillin) and an azolide antibiotic azithromycin, firm reported at April 27 annual meeting. An injectable form of Unasyn (sulbactam/ampicillin) was approved for U.S. marketing in December 1987. Pfizer currently has eight NDAs pending at FDA, the company said. Among drugs pending agency approval are the antifungal Diflucan (fluconazole), filed March 1, Xomen-E5, Xoma's monoclonal antibody-based treatment for gram negative sepsis developed in conjunction with Pfizer, Procardia XL, Minipress XL, the vasodilator Cardura (see related story), Norvasc, the anti-depressant sertraline, and the selective antihistamine cetirizine.
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