ISTA begins full-scale commercial operations in preparation for ISTALOL(TM) launch
ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News) today announced that the U.S. Food & Drug Administration ("FDA") has approved the New Drug Application ("NDA") for ISTALOL(TM), a once- a-day liquid formulation of timolol, for the treatment of glaucoma.
Thomas K. Mundorf, M.D., a leading ophthalmologist and a clinical investigator for the U.S. ISTALOL(TM) clinical studies, commented, "Because glaucoma is a serious, chronic disease that must be treated for life, it is important to offer patients alternatives in their treatment regimen. ISTALOL(TM) gives patients an effective, therapeutic option with the convenience of a once-daily formulation. I believe that this is an advance that patients and their caregivers will greatly appreciate."
ISTALOL(TM) is ISTA's second product approved by the FDA. In May, ISTA announced FDA approval of ISTA's NDA for VitraseĀ® (hyaluronidase for injection; lyophilized, ovine) for use as a spreading agent to facilitate the dispersion and absorption of other drugs.
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ISTA Pharmaceuticals Receives FDA Approval for ISTALOL(TM) for the Treatment of Glaucoma