Inpharma 1234 - 22 Apr 2000

Regulatory news from the USThe US FDA has approved verteporfin [‘Visudyne’;

CIBA Vision, QLT PhotoTherapeutics] for the treatmentof the wet form of age-related macular degeneration inpatients with predominantly classic subfoveal choroidalneovascularisation.1 Verteporfin is the first drug to beapproved in the US in this indication. The drug hasalready been approved in Switzerland and Malta, and isawaiting regulatory approval in a number of othercountries, including Argentina, Australia, Brazil, Canada,Iceland, India, New Zealand and Norway.

The FDA has also approved meloxicam [‘Mobic’] forthe treatment of osteoarthritis.2 Meloxicam will bemarketed jointly by Abbott Laboratories and BoehringerIngelheim.

Tegaserod [‘Zelmac’; Novartis] has been grantedpriority review status by the FDA.3 Tegaserod isindicated for the treatment of symptoms of irritablebowel syndrome.

Finally, the FDA has granted orphan drug status toMatrix Pharmaceutical’s antineoplastic agent MPI-5010[‘IntraDose’] for the treatment of squamous cellcarcinoma of the head and neck.4 MPI-5010 contains acombination of cisplatin and epinephrine [adrenaline].1. Novartis AG. FDA approves Visudyne(TM) therapy for AMD; a major advance

in ophthalmology. Media Release : [3 pages], 13 Apr 2000. Available from:URL: http://www.novartis.com.

2. Boehringer Ingelheim Pharmaceuticals Inc. FDA approval means Americanswith osteoarthritis have a new option. Media Release : [2 pages], 14 Apr 2000.Available from: URL: http://www.boehringer-ingelheim.com.

3. Novartis Pharmaceuticals Corporation. Zelmac (TM) (tegaserod) granted priorityreview by FDA for the treatment of irritable bowel syndrome. Media Release :[2 pages], 12 Apr 2000. Available from: URL: http://www.novartis.com.

4. Matrix Pharmaceutical Inc. FDA grants orphan drug status for IntraDose. MediaRelease : [1 page], 13 Apr 2000. Available from: URL: http://www.matx.com.

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Inpharma 22 Apr 2000 No. 12341173-8324/10/1234-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved