YEAR-END FDA APPROVALS

In characteristic fashion, the US Food and Drug Administration ended the year with its usual last-minute batch of approvals, and some of the industry majors' products figure in the round-up.

SmithKline Beecham received marketing approval for its non-steroidal anti-inflammatory drug Relafen (nabumetone), which it claims is less ulcer-inducing than other products of this type. Relafen is indicated for severe arthritis, particularly rheumatoid arthritis and osteoarthritis. The product joins a crowded market, with 15 NSAID products already available in the USA for this indication. However, Relafen is marketed in several other countries, where it has achieved annual sales of about $50 million, and some analysts have speculated that the inclusion of the US market may bump this total up to $200 million by the end of 1992.

Hoffmann-La Roche's Mazicon (flumazenil) has also been approved. The drug reverses the sedative effects of benzodiazepine drugs, and is expected to be widely used both as a treatment for benzodiazepine overdose and to help anesthetized patients wake up after surgery. Analysts at Shearson-Lehman have predicted that this will be a drug of medium potential market size, with peak worldwide sales reaching between $100 million and $250 million.