Inpharma 1366 - 30 Nov 2002 US FDA product news GlaxoSmithKline’s oral combination treatment comprising rosiglitazone and metformin [‘Avandamet’] has been launched in the US for use in patients with type 2 diabetes mellitus, as an adjuvant to diet and exercise, according to Scrip. 1 Alosetron [‘Lotronex’; GlaxoSmithKline] tablets are now available in the US under restricted conditions of use, specifically for women with severe diarrhoea- predominant irritable bowel syndrome (IBS) who have failed to respond to conventional therapy, whose IBS symptoms are chronic and in whom other gastrointestinal medical conditions that could explain their symptoms have been excluded. 2 The US FDA has approved nitazoxanide [‘Alinia’; Romark] for the treatment of paediatric patients with diarrhoea caused by Cryptosporidium parvum and Giardia lambiia, reports the Pink Sheet. 3 Fougera, a division of Atlanta Inc., has received FDA approval for the marketing of its topical antifungal medication, econazole cream 1%, a generic form of Ortho Dermatological’s ‘Spectazole’. 4 The product is indicated for the treatment of tinea corporis, tinea cruris and tinea pedis. Merck KGaA’s Canadian subsidiary Genpharm has received FDA approval to market a generic version of Roche’s acne drug isotretinoin, reports Marketletter. 5 Genpharm will market isotretinoin as soft gelatine capsules under the trade name of ‘Amnesteem’. The FDA has tentatively approved the marketing of Andrx Corporation’s abbreviated new drug application for loratadine rapidly-disintegrating tablets, which are bioequivalent to Schering-Plough Corporation’s ‘Claritin Reditabs’. 6 The product is indicated for the treatment of seasonal allergic rhinitis. The FDA has issued an approvable letter to Dr Reddy’s Laboratories for its new drug application for amlodipine, a new formulation of Pfizer’s antihypertensive ‘Norvasc’, reports Scrip. 7 An FDA advisory panel has voted in favour of approving Wyeth-Ayerst’s BMP-2 [recombinant human bone morphogenic protein-2; ‘InductOs’], with several approval conditions, including the stipulation that it should be used only for problem fractures. 8 Wyeth- Ayerst is seeking approval of ‘InductOs’ for the treatment of acute long-bone fractures requiring open surgical management. 1. GlasoSmithKline’s Avandamet launched in the US. Scrip : 18, No. 2799, 15 Nov 2002. 2. GlaxoSmithKline. Lotronex(R) Tablets Now Available for Women with Severe Diarrhea-Predominant Irritable Bowel Syndrome. Media Release : 20 Nov 2002. Available from: URL: http://www.gsk.com. 3. Romark Alinia approved. FDC Reports - Pink Sheet - Prescription Pharmaceuticals and Biotechnology 64: [1 page], 25 Nov 2002. Available from: URL: http://www.fdcreports.com. 4. Fougera. Another First for Fougera; First FDA Approval for Econazole Nitrate Cream 1% (Rx). Media Release : 26 Nov 2002. Available from: URL: http:// www.fougera.com. 5. Roche faces generic Accutane in USA. Marketletter [Copy 2] 29: 19, 18 Nov 2002. 6. Andrx Corporation. Andrx Granted FDA Tentative Approval of Generic Claritin Reditabs. Media Release : 18 Nov 2002. Available from: URL: http:// www.andrx.com. 7. Dr Reddy’s amlodipine approvable in US. Scrip : 16, No. 2796, 6 Nov 2002. 8. FDA Advisory Committee. Wyeth InductOs BMP-2 use should be limited to problem fractures, panel says. Internet Document : [3 pages], 25 Nov 2002. Available from: URL: http://www.fdaadvisorycommittee.com. 800888664 1 Inpharma 30 Nov 2002 No. 1366 1173-8324/10/1366-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1366 - 30 Nov 2002

US FDA product newsGlaxoSmithKline’s oral combination treatment

comprising rosiglitazone and metformin [‘Avandamet’]has been launched in the US for use in patients with type2 diabetes mellitus, as an adjuvant to diet and exercise,according to Scrip.1

Alosetron [‘Lotronex’; GlaxoSmithKline] tablets arenow available in the US under restricted conditions ofuse, specifically for women with severe diarrhoea-predominant irritable bowel syndrome (IBS) who havefailed to respond to conventional therapy, whose IBSsymptoms are chronic and in whom othergastrointestinal medical conditions that could explaintheir symptoms have been excluded.2

The US FDA has approved nitazoxanide [‘Alinia’;Romark] for the treatment of paediatric patients withdiarrhoea caused by Cryptosporidium parvum andGiardia lambiia, reports the Pink Sheet.3

Fougera, a division of Atlanta Inc., has received FDAapproval for the marketing of its topical antifungalmedication, econazole cream 1%, a generic form ofOrtho Dermatological’s ‘Spectazole’.4 The product isindicated for the treatment of tinea corporis, tinea crurisand tinea pedis.

Merck KGaA’s Canadian subsidiary Genpharm hasreceived FDA approval to market a generic version ofRoche’s acne drug isotretinoin, reports Marketletter.5Genpharm will market isotretinoin as soft gelatinecapsules under the trade name of ‘Amnesteem’.

The FDA has tentatively approved the marketing ofAndrx Corporation’s abbreviated new drug applicationfor loratadine rapidly-disintegrating tablets, which arebioequivalent to Schering-Plough Corporation’s ‘ClaritinReditabs’.6 The product is indicated for the treatment ofseasonal allergic rhinitis.

The FDA has issued an approvable letter to Dr Reddy’sLaboratories for its new drug application foramlodipine, a new formulation of Pfizer’santihypertensive ‘Norvasc’, reports Scrip.7

An FDA advisory panel has voted in favour ofapproving Wyeth-Ayerst’s BMP-2 [recombinant humanbone morphogenic protein-2; ‘InductOs’], with severalapproval conditions, including the stipulation that itshould be used only for problem fractures.8 Wyeth-Ayerst is seeking approval of ‘InductOs’ for thetreatment of acute long-bone fractures requiring opensurgical management.1. GlasoSmithKline’s Avandamet launched in the US. Scrip : 18, No. 2799, 15

Nov 2002.2. GlaxoSmithKline. Lotronex(R) Tablets Now Available for Women with Severe

Diarrhea-Predominant Irritable Bowel Syndrome. Media Release : 20 Nov 2002.Available from: URL: http://www.gsk.com.

3. Romark Alinia approved. FDC Reports - Pink Sheet - PrescriptionPharmaceuticals and Biotechnology 64: [1 page], 25 Nov 2002. Available from:URL: http://www.fdcreports.com.

4. Fougera. Another First for Fougera; First FDA Approval for Econazole NitrateCream 1% (Rx). Media Release : 26 Nov 2002. Available from: URL: http://www.fougera.com.

5. Roche faces generic Accutane in USA. Marketletter [Copy 2] 29: 19, 18 Nov2002.

6. Andrx Corporation. Andrx Granted FDA Tentative Approval of Generic ClaritinReditabs. Media Release : 18 Nov 2002. Available from: URL: http://www.andrx.com.

7. Dr Reddy’s amlodipine approvable in US. Scrip : 16, No. 2796, 6 Nov 2002.8. FDA Advisory Committee. Wyeth InductOs BMP-2 use should be limited to

problem fractures, panel says. Internet Document : [3 pages], 25 Nov 2002.Available from: URL: http://www.fdaadvisorycommittee.com.

800888664