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Executive Summary

FISONS' SECOND CROMOLYN SODIUM ORPHAN DRUG GASTROCROM will be launched in the last week of January, the firm said after receiving FDA approval on Dec. 22. The agency approved the drug after a six-year NDA review. Official labeling states that "Gastrocrom is indicated in the management of patients with mastocytosis." Use of the product "has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients," the package insert notes. Available in 100 mg capsules, Gastrocrom is the first oral formulation of cromolyn sodium to be marketed by Fisons. Gastrocrom will be available in bottles of 100 at a direct price to wholesalers of $69.80. The company estimates that the U.S. patient population for Gastrocrom could range anywhere from "1,000 to 10-20,000." Fisons' Opticrom, a sodium cromolyn ophthalmic solution for the treatment of certain allergic ocular disorders, became in 1984 the company's first product to receive an orphan drug approval. By developing new orphan indications for the compound, Fisons is expanding on its established cromolyn sodium respiratory franchise, which includes products such as Nasalcrom and Intal.

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