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Executive Summary

NAPHAZOLINE AND/OR ANTAZOLINE COMBO OPHTHALMICS CANNOT BE MARKETED without an approved NDA, FDA's Division of Drug Labeling Compliance notified district directors in a June 11 memorandum. The notice is to "advise the Districts of a regulatory class action being implemented against unapproved prescription ophthalmic solutions containing antazoline phosphate or naphazoline hydrochloride in combination with other active ingredients for the relief of signs and symptoms of allergic conjunctivitis," the memo explains. On the same day it sent the memo, FDA distributed warning letters to 21 manufacturers and distributors listed by the agency as marketing combination antihistamine/vasoconstrictor ophthalmic products. Receiving the warning letters were Alcon Labs, Allergan, Aligen, DRX, Geneva Generics, Goldline Labs, ISP, Infinity, Major, Martec, Medical Ophthalmics, Med-Pro, Ocusoft, Optopics Labs, Parmed, Pharmafair, Pharmedix, Schein, Steris Labs, Storz Ophthalmics and Rugby Labs. Firms are asked in the warning letter to submit a reply within 15 days of receipt containing estimates of the amount of the cited drug manufactured/received and the size and frequency of shipments in the last year; an estimate of inventory that is within and outside of the firm's control; the firm's plans regarding inventory and stock "in trade channels"; and the date, if any, that the firm discontinued manufacture of the drug. The ophthalmic solutions had been marketed under FDA's Drug Efficacy Study Implementation (DESI) program. However, in an Oct. 1, 1992 Federal Register notice, the agency announced a final evaluation of naphazoline/antazoline combination products, finding only Iolab's Vasocon-A (antazoline .5%, naphazoline .05%) safe and effective for the relief of the signs and symptoms of allergic conjunctivitis. Iolab's NDA for the product was approved in April 1990. FDA's memorandum to district directors explains that the Oct. 1 notice "triggers enforcement requirements that all identical, related or similar unapproved products (e.g., unapproved ophthalmic products containing an antihistamine in combination with vasoconstrictor) either secure approved applications or be removed from the market." Alcon Labs, marketer of Naphcon-A, said June 16 that it "totally supports and endorses FDA's approach under DESI to remove old drugs from the market whenever an NDA has not been filed. In the case of Naphcon-A, an NDA has been filed and is currently under active FDA review. Additional data are being submitted as requested by the FDA. As has been the case with other DESI- reviewed drugs, Alcon expects to continue marketing Naphcon-A through the completion of the NDA process." Naphcon-A, a naphazoline/pheniramine maleate combination, has been marketed for over 14 years, and the Nestle, S.A. unit claims the product is "the most widely prescribed antihistamine- decongestant product by ophthalmologists in the United States." Allergan manufactures two products cited by FDA: Albalon-A (naphazoline/antazoline) and Prefrin-A (phenylephrine/pyrilamine maleate). Sales of the products account for less than 1% of the firm's U.S. pharmaceutical sales, Allergan said. Schein, which manufactures a naphazoline/antazoline combo, said it stopped production "some months ago" and is now determining whether it will submit an NDA for the drug. Martec Pharmaceutical, which distributes Optopics Lab's naphazoline/pheniramine maleate under its own label, said it stopped shipment and quarantined the drug after receiving the warning letter and is discussing further action, including a possible recall, with Optopics. In the past year, Martec sold 6,449 bottles of the drug, which retails for $1.92 per bottle.

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