Inpharma 1306 - 22 Sep 2001 News from the US market The rapid-acting insulin analogue insulin aspart [‘NovoLog’; Novo Nordisk] has been launched in the US for the treatment of adults with diabetes mellitus. 1 The US FDA has approved darbepoetin alfa [‘Aranesp’; Amgen] for the treatment of anaemia associated with chronic renal failure. 2 Darbepoetin alfa is indicated for use both in patients undergoing dialysis and those who are not on dialysis. The human skin replacement product ‘OrCel’ [Ortec International] has been approved by the FDA for healing donor site wounds in patients with burns, reports Marketletter. 3 Actelion has been issued with an approvable letter from the FDA for the endothelin receptor antagonist bosentan [‘Tracleer’], which has been developed for the treatment of pulmonary arterial hypertension. 4 The FDA has granted fast track status to sulodexide [Keryx Biopharmaceuticals] for the treatment of diabetic nephropathy. 5 In addition, the FDA has granted priority review status to an application from Immunex to expand the approved indications for etanercept [‘Enbrel’], to allow its use in the treatment of psoriatic arthritis. 6 1. Novo Nordisk Pharmaceuticals Inc. New rapid-acting insulin analog, NovoLog (R), now available in U.S. Media Release : [2 pages], 18 Sep 2001. Available from: URL: http://www.novonordisk.com. 2. Amgen. FDA approves Amgen’s Aranesp (TM) for anemia associated with chronic renal failure. Media Release : [4 pages], 18 Sep 2001. Available from: URL: http://www.amgen.com. 3. FDA OKs Ortec’s OrCel. Marketletter [Copy 2] 28: 23, 10 Sep 2001. 4. Actelion Ltd. Tracleer receives approvable letter from the FDA. Media Release : [2 pages], 17 Sep 2001. Available from: URL: http://www.actelion.com. 5. Keryx Biopharmaceuticals Inc. Keryx Biopharmaceuticals granted fast track status by the U.S. Food and Drug Administration. Media Release : [3 pages], 7 Sep 2001. Available from: URL: http://www.keryx.com. 6. Immunex Corporation. FDA assigns priority review status to ENBREL (R) (etanercept) sBLA for treatment of psoriatic arthritis. Media Release : [3 pages], 17 Sep 2001. Available from: URL: http://www.immunex.com. 800840804 1 Inpharma 22 Sep 2001 No. 1306 1173-8324/10/1306-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1306 - 22 Sep 2001

News from the US marketThe rapid-acting insulin analogue insulin aspart

[‘NovoLog’; Novo Nordisk] has been launched in the USfor the treatment of adults with diabetes mellitus.1

The US FDA has approved darbepoetin alfa[‘Aranesp’; Amgen] for the treatment of anaemiaassociated with chronic renal failure.2 Darbepoetin alfais indicated for use both in patients undergoing dialysisand those who are not on dialysis.

The human skin replacement product ‘OrCel’[Ortec International] has been approved by the FDA forhealing donor site wounds in patients with burns,reports Marketletter.3

Actelion has been issued with an approvable letterfrom the FDA for the endothelin receptor antagonistbosentan [‘Tracleer’], which has been developed for thetreatment of pulmonary arterial hypertension.4

The FDA has granted fast track status to sulodexide[Keryx Biopharmaceuticals] for the treatment of diabeticnephropathy.5

In addition, the FDA has granted priority review statusto an application from Immunex to expand the approvedindications for etanercept [‘Enbrel’], to allow its use inthe treatment of psoriatic arthritis.6

1. Novo Nordisk Pharmaceuticals Inc. New rapid-acting insulin analog, NovoLog(R), now available in U.S. Media Release : [2 pages], 18 Sep 2001. Availablefrom: URL: http://www.novonordisk.com.

2. Amgen. FDA approves Amgen’s Aranesp (TM) for anemia associated withchronic renal failure. Media Release : [4 pages], 18 Sep 2001. Available from:URL: http://www.amgen.com.

3. FDA OKs Ortec’s OrCel. Marketletter [Copy 2] 28: 23, 10 Sep 2001.4. Actelion Ltd. Tracleer receives approvable letter from the FDA. Media Release :

[2 pages], 17 Sep 2001. Available from: URL: http://www.actelion.com.5. Keryx Biopharmaceuticals Inc. Keryx Biopharmaceuticals granted fast track

status by the U.S. Food and Drug Administration. Media Release : [3 pages], 7Sep 2001. Available from: URL: http://www.keryx.com.

6. Immunex Corporation. FDA assigns priority review status to ENBREL (R)(etanercept) sBLA for treatment of psoriatic arthritis. Media Release : [3 pages],17 Sep 2001. Available from: URL: http://www.immunex.com.

800840804