22 MARKET NEWS OTC naproxen gains FDA approval

An over-the-counter (OTC) analgesic based on naproxen will be available in the US by mid-1994, reports the Wall Street Journal [12 Jan]. The OTC formulation, to be marketed as Aleve®, will become the first nonprescription analgesic to enter the market (estimated at $US2.3 billion) since ibuprofen was approved a decade earlier.

In approving the OTC product, the US FDA took the unusual step of overruling an advisory committee [see Inpharma 891: 23, 12 Jun 1993]. However, the FDA said that it addressed the committee's concerns by asking for the daily dosage to be lowered (from 800 to 600mg), a longer duration between pills (8-12

hours instead of 6--12 hours) and inclusion of label warnings regarding use in children and the elderly.

Analysts predict that Aleve®, the result of a joint venture between Proctor & Gamble and Syntex, may gain a 10-20% marketshare.

Withdrawal for ketoroIac,remoxipride The licence for Syntex' NSAID ketorolac

[Toradol®] has been withdrawn by French authorities. This action was taken because a national pharmaco­vigilance investigation revealed an abnormally high incidence and severity rate of haemorrhagic events in patients treated with the drug.

Astra has announced that it will withdraw the anti­psychotic remoxipride [Roxiam®] from its worldwide markets. Remoxipride has been associated with aplastic anaemia. The drug will remain available for compassionate use.

For more information on these events see the Drug Reactions section, this issue, p21.

22 Jan 1994INPHARMA'" 0156·2703194/0921·00221$1.00" Adls Interna1ional Limited 1994. All rights reserved