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DRUG REACTIONS
US FDA news update To mid-April, the US FDA had approved 4 new
chemical entities this y~ar. These were: • Loratadine [Claritin j: Schering-Plough's
non sedating antihistamine for seasonal allergic rhinitis.
• Cladribine [Leustatin~: a hairy cell leukaemia therapy developed by J~hnson & Johnson.
• Enoxaparin [Lovenoxj: a Rh6ne-Poulenc Rorer product approved for the prevention of deep vein thrombosis. It was the fust low molecular weight heparin to be approved in the US.
• Gadodiamide [Omniscan~: Eastman Kodak's nonionic contrast medium for magnetic resonance imaging. A further II new chemical entities have been
recommended for approval by FDA advisory committees. Among these, approval is expected shortly fo~ the anticonvulsant, felbamate [Felbatol ], the gast~p-oesophageal reflux therapy, cisapride [Propulsid ] and~e Alzheimer's disease treatment, tacrine [Cognex ].
The FDA has also been active in reviewing biological products and 4 have been ap~roved: • Recombinant factor VIII [Kogenatej: Miles/
Genentech's haemophilia A prophylactic agent. • Tetramune®: a combined vaccine against
Haemophilus B, diphtheria, tetanus and pertussis developed by Lederle.
• ActHib Haemophilus B vaccine: a SmithKline Beecham product.
• Epoetin-a [Procrit®]: Johnson & Johnson's agent for antineoplastic-induced anaemia.
ISSN 0156-270319310605-003IS1.rxf' Adlalntern8tlonal Ltd
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