Inpharma 1273 - 3 Feb 2001 US FDA regulatory news The US FDA has approved Smith & Nephew’s hyaluronan product ‘Supartz’ for the treatment of osteoarthritis of the knee. 1 ‘Supartz’ is manufactured by Seikagaku Corporation. FDA approval has also been granted to caspofungin [‘Cancidas’; Merck & Co.] for the treatment of patients with invasive aspergillosis who have not responded to, or who are unable to tolerate, standard antifungal therapy. 2 Caspofungin is the first approved drug in a new class of antifungals, the echinocandins. Praecis Pharmaceuticals’ New Drug Application for the depot formulation of abarelix has been awarded priority review status by the FDA. 3 The hormonal product is indicated for the treatment of prostate cancer. Two generic versions of Solvay Pharmaceuticals’ fluvoxamine product ‘Luvox’, indicated for the treatment of obsessive compulsive disorder, have been approved by the FDA. 45 The generic fluvoxamine products are manufactured by Barr Laboratories and Synthon Pharmaceuticals. FDA approval has also been granted to Barr Laboratories for its generic version of amiodarone, in 200mg tablets. 6 The product is the generic equivalent of Wyeth-Ayerst’s ‘Cordarone’, indicated for the treatment of recurrent ventricular fibrillation and recurrent haemodynamically unstable ventricular tachycardia. MTC-DOX [FeRx] has been given orphan drug status by the FDA for use in the treatment of patients with primary liver cancer. 7 The FDA has issued an approvable letter to Schering- Plough for its antihistamine desloratadine. 8 The product is indicated for the treatment of seasonal allergic rhinitis. 1. Smith & Nephew Orthopaedics. Smith & Nephew announces FDA approval of Supartz. Media Release : [2 pages], 29 Jan 2001. Available from: URL: http:// www.supartz.com. 2. Food and Drug Administration. FDA approves new treatment for invasive fungal infection. Media Release : [2 pages], 29 Jan 2001. Available from: URL: http://www.fda.gov. 3. Praecis Pharmaceuticals Incorporated. Praecis Pharmaceuticals Incorporated announces FDA priority review and filing of its abarelix depot NDA for prostate cancer. Media Release : [2 pages], 25 Jan 2001. 4. Barr Laboratories Inc. Barr receives approval for generic LUVOX (R) tablets. Media Release : [2 pages], 26 Jan 2001. Available from: URL: http:// www.barrlabs.com. 5. Synthon Pharmaceuticals Ltd. Synthon Pharmaceuticals receives approval on fluvoxamine maleate tablets. Media Release : [2 pages], 23 Jan 2001. Available from: URL: http://www.synthon-usa.com. 6. Barr Laboratories Inc. Barr receives approval for generic Cordarone (R) tablets. Media Release : [2 pages], 29 Jan 2001. Available from: URL: http:// www.barrlabs.com. 7. FeRx Inc. FeRx receives orphan drug designation for MTC-DOX for treatment of liver cancer. Media Release : [2 pages], 29 Jan 2001. Available from: URL: http://www.ferx.com. 8. Schering-Plough Corporation. Schering-Plough reports desloratadine receives FDA approvable letter. Media Release : [1 page], 25 Jan 2001. Available from: URL: http://www.schering-plough.com. 800840378 1 Inpharma 3 Feb 2001 No. 1273 1173-8324/10/1273-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1273 - 3 Feb 2001

US FDA regulatory newsThe US FDA has approved Smith & Nephew’s

hyaluronan product ‘Supartz’ for the treatment ofosteoarthritis of the knee.1 ‘Supartz’ is manufactured bySeikagaku Corporation.

FDA approval has also been granted to caspofungin[‘Cancidas’; Merck & Co.] for the treatment of patientswith invasive aspergillosis who have not responded to,or who are unable to tolerate, standard antifungaltherapy.2 Caspofungin is the first approved drug in anew class of antifungals, the echinocandins.

Praecis Pharmaceuticals’ New Drug Application forthe depot formulation of abarelix has been awardedpriority review status by the FDA.3 The hormonalproduct is indicated for the treatment of prostate cancer.

Two generic versions of Solvay Pharmaceuticals’fluvoxamine product ‘Luvox’, indicated for thetreatment of obsessive compulsive disorder, have beenapproved by the FDA.45 The generic fluvoxamineproducts are manufactured by Barr Laboratories andSynthon Pharmaceuticals.

FDA approval has also been granted to BarrLaboratories for its generic version of amiodarone, in200mg tablets.6 The product is the generic equivalent ofWyeth-Ayerst’s ‘Cordarone’, indicated for the treatmentof recurrent ventricular fibrillation and recurrenthaemodynamically unstable ventricular tachycardia.

MTC-DOX [FeRx] has been given orphan drug statusby the FDA for use in the treatment of patients withprimary liver cancer.7

The FDA has issued an approvable letter to Schering-Plough for its antihistamine desloratadine.8 Theproduct is indicated for the treatment of seasonalallergic rhinitis.1. Smith & Nephew Orthopaedics. Smith & Nephew announces FDA approval of

Supartz. Media Release : [2 pages], 29 Jan 2001. Available from: URL: http://www.supartz.com.

2. Food and Drug Administration. FDA approves new treatment for invasivefungal infection. Media Release : [2 pages], 29 Jan 2001. Available from: URL:http://www.fda.gov.

3. Praecis Pharmaceuticals Incorporated. Praecis Pharmaceuticals Incorporatedannounces FDA priority review and filing of its abarelix depot NDA for prostatecancer. Media Release : [2 pages], 25 Jan 2001.

4. Barr Laboratories Inc. Barr receives approval for generic LUVOX (R) tablets.Media Release : [2 pages], 26 Jan 2001. Available from: URL: http://www.barrlabs.com.

5. Synthon Pharmaceuticals Ltd. Synthon Pharmaceuticals receives approval onfluvoxamine maleate tablets. Media Release : [2 pages], 23 Jan 2001. Availablefrom: URL: http://www.synthon-usa.com.

6. Barr Laboratories Inc. Barr receives approval for generic Cordarone (R) tablets.Media Release : [2 pages], 29 Jan 2001. Available from: URL: http://www.barrlabs.com.

7. FeRx Inc. FeRx receives orphan drug designation for MTC-DOX for treatmentof liver cancer. Media Release : [2 pages], 29 Jan 2001. Available from: URL:http://www.ferx.com.

8. Schering-Plough Corporation. Schering-Plough reports desloratadine receivesFDA approvable letter. Media Release : [1 page], 25 Jan 2001. Available from:URL: http://www.schering-plough.com.

800840378