Inpharma 1258 - 7 Oct 2000 Regulatory decisions from the US FDA Serono’s recombinant chorionic gonadotropin [‘Ovidrel’] has been approved by the US FDA for use in women being treated for infertility. 1 ‘Ovidrel’ is the first chorionic gonadotropin product approved in the US for SC administration. Serono anticipates a US launch for recombinant chorionic gonadotropin to take place by the first quarter of 2001. The FDA has also approved mifepristone [‘Mifeprex’] for the termination of early pregnancy (i.e. within 49 days of the beginning of the last menstrual period). 2 The approval requires that mifepristone be distributed to physicians who can accurately determine the duration of pregnancy and can detect ectopic pregnancy. Physicians will also be required to have facilities to provide surgical intervention in the event of incomplete abortion or severe bleeding, or to have made alternative plans for such care in advance. Mifepristone will be distributed in the US by Danco Laboratories. A new cream formulation of tazarotene [‘Tazorac’; Allergan] has been approved by the FDA for the treatment of plaque psoriasis. 3 ‘Fosamax’ approved for osteoporosis in men The FDA has approved a new indication for alendronic acid [‘Fosamax’; Merck & Co.], allowing it to be used for the treatment of men with osteoporosis, to increase bone mass. 4 Alendronic acid is the first product to be approved in the US for this indication. Alendronic acid was already approved for the prevention and treatment of postmenopausal osteoporosis, the treatment of Paget’s disease of bone and the treatment of corticosteroid-induced osteoporosis in men and women. Finally, an approvable letter has been issued by the FDA for zoledronic acid [‘Zometa’; Novartis] for the treatment of hypercalcaemia of malignancy. 5 1. Serono Inc. Serono receives first US marketing approval for recombinant fertility drug to trigger ovulation. Media Release : [3 pages], 2 Oct 2000. Available from: URL: http://www.serono.com. 2. Food and Drug Administration. FDA approves mifepristone for the termination of early pregnancy. Media Release : [2 pages], 2 Oct 2000. Available from: URL: http://www.fda.gov. 3. Allergan Inc. Allergan’s Tazorac receives U.S. FDA approval for a new cream formulation. Media Release : [2 pages], 2 Oct 2000. Available from: URL: http:/ /www.allergan.com. 4. Merck & Co Inc. Fosamax (R) receives FDA approval for use in men. Media Release : [3 pages], 2 Oct 2000. Available from: URL: http://www.merck.com. 5. Novartis. Novartis receives FDA approvable letter for Zometa (Rm), a new therapy to treat an important complication of cancer. Media Release : [2 pages], 22 Sep 2000. Available from: URL: http://www.novartis.com. 800840131 1 Inpharma 7 Oct 2000 No. 1258 1173-8324/10/1258-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Regulatory decisions from the US FDA

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Inpharma 1258 - 7 Oct 2000

Regulatory decisions from the USFDA

Serono’s recombinant chorionic gonadotropin[‘Ovidrel’] has been approved by the US FDA for use inwomen being treated for infertility.1 ‘Ovidrel’ is the firstchorionic gonadotropin product approved in the US forSC administration. Serono anticipates a US launch forrecombinant chorionic gonadotropin to take place bythe first quarter of 2001.

The FDA has also approved mifepristone [‘Mifeprex’]for the termination of early pregnancy (i.e. within 49days of the beginning of the last menstrual period).2

The approval requires that mifepristone be distributedto physicians who can accurately determine the durationof pregnancy and can detect ectopic pregnancy.Physicians will also be required to have facilities toprovide surgical intervention in the event of incompleteabortion or severe bleeding, or to have made alternativeplans for such care in advance. Mifepristone will bedistributed in the US by Danco Laboratories.

A new cream formulation of tazarotene [‘Tazorac’;Allergan] has been approved by the FDA for thetreatment of plaque psoriasis.3

‘Fosamax’ approved for osteoporosis in menThe FDA has approved a new indication for

alendronic acid [‘Fosamax’; Merck & Co.], allowing itto be used for the treatment of men with osteoporosis,to increase bone mass.4 Alendronic acid is the firstproduct to be approved in the US for this indication.

Alendronic acid was already approved for theprevention and treatment of postmenopausalosteoporosis, the treatment of Paget’s disease of boneand the treatment of corticosteroid-inducedosteoporosis in men and women.

Finally, an approvable letter has been issued by theFDA for zoledronic acid [‘Zometa’; Novartis] for thetreatment of hypercalcaemia of malignancy.5

1. Serono Inc. Serono receives first US marketing approval for recombinantfertility drug to trigger ovulation. Media Release : [3 pages], 2 Oct 2000.Available from: URL: http://www.serono.com.

2. Food and Drug Administration. FDA approves mifepristone for the terminationof early pregnancy. Media Release : [2 pages], 2 Oct 2000. Available from:URL: http://www.fda.gov.

3. Allergan Inc. Allergan’s Tazorac receives U.S. FDA approval for a new creamformulation. Media Release : [2 pages], 2 Oct 2000. Available from: URL: http://www.allergan.com.

4. Merck & Co Inc. Fosamax (R) receives FDA approval for use in men. MediaRelease : [3 pages], 2 Oct 2000. Available from: URL: http://www.merck.com.

5. Novartis. Novartis receives FDA approvable letter for Zometa (Rm), a newtherapy to treat an important complication of cancer. Media Release : [2 pages],22 Sep 2000. Available from: URL: http://www.novartis.com.

800840131