ALLERGAN's NDA FILING FOR BETA BLOCKER LEVOBUNOLOL MAKES THREE NDAs

Executive Summary

ALLERGAN's NDA FILING FOR BETA BLOCKER LEVOBUNOLOL MAKES THREE NDAs filed by the SmithKline Beckman subsidiary in the past four months, according to SmithKline's just-released annual report for 1983. The levobunolol NDA for the treatment of glaucoma was filed with FDA "in early 1984," the report notes. Internatl. filings for the beta blocker, licensed from Warner-Lambert, "are underway," the annual report adds. In addition to the levobunolol NDA, SmithKline reports, Allergan filed NDAs in December for two other products: an unnamed steroid/antibiotic combination and a higher dosage form of the steroid anti-inflammatory FML. SmithKline's Allergan eye and skin care business, which includes Herbert Labs, continues to be one of several steady growth business segments for the diversified healthcare firm. In 1983, Allergan's sales jumped nearly 17% to $202 mil. after a 25% sales gain the previous year. The firm's dermatology div., Herbert Labs, "completed its second year as a separate operating unit with good growth prospects in Rx dermatology," the annual report notes. As part of the div.'s move out of the OTC product area and into the Rx dermatology market, Herbert Labs signed an agreement last October with Sandoz subsidiary Dorsey to exchange Herbert's Eclipse suncare product line for Dorsey's Gris-PEG Rx anti-fungal. While Herbert Labs in marketing Gris-PEG, an oral form of griseofulvin, Allergan is working with former subsidiary Nelson R&D on a topical form of griseofulvin (Griseoderm) using Nelson's Azone transdermal technology. An NDA for Grisoderm was filed with FDA in 1981 and is still pending. Herbert Labs is also developing another anti-fungal product licensed from Sandoz called naftifine. SmithKline noted that an NDA for the broad spectrum anti-fungal "is expected to be filed by mid-1984."