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IOLAB’s LIVOSTIN OPHTHALMIC SUSPENSION APPROVED NOV. 10

Executive Summary

IOLAB's LIVOSTIN OPHTHALMIC SUSPENSION APPROVED NOV. 10 for "temporary relief of the signs and symptoms of seasonal allergic conjunctivitis" (SAC), labeling states. Livostin (levocabastine, under development by the Johnson & Johnson unit as Levocon) was classified "1P" by FDA, designating a new molecular entity that received priority review from the agency. FDA's approval letter notes that the NDA (20-219) was filed on Sept. 20, 1991 and the last amendment to the NDA was received Nov. 10. Livostin is a selective histamine H[1],- receptor antagonist for ophthalmic uses, labeling states. Labeling notes that "antigen challenge studies performed two to four hours after initial drug instillation showed that activity was maintained for at least two hours." Livostin will join two other Iolab prescription products on the market that are indicated for SAC: Inflamase (prednisolone sodium phosphate) and the combination product Vasocon-A (antazoline phosphate/naphazoline). Other ophthalmic products designated for SAC include antihistamine/decongestant combinations, nonsteroidal anti-inflammatory drugs and steroids. For treatment of SAC, Livostin's usual dose is "one drop instilled in affected eyes four times a day" for up to two weeks. Mild, transient stinging and burning occurred in 15% of patients and 5% experienced headaches, approved labeling states. Visual disturbances, dry mouth, fatigue, pharyngitis, eye pain and dryness, somnolence, red eyes, cough, nausea, rash, eyelid edema and dyspnea was reported in 3% or less of Livostin users. Livostin is not recommended for use while contact lenses are being worn. The agency approval letter notes Iolab's commitment in an Oct. 13 NDA amendment "to correct bottle and carton labels when the current supply of 100,000 is exhausted or at the next printing." Additionally, FDA requests that Claremont, Calif.-based Iolab "provide the thermo-gravimetric and X-ray powder diffraction analyses of the drug substance made under the old and the new processes." Livostin is supplied in 2.5 ml, 5 ml and 10 ml polyethylene dropper tip squeeze bottles. Iolab, which plans to launch Livostin in the "near future," says it has not yet established the product's price.
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