Inpharma 1352 - 24 Aug 2002 Market news from the US LAM Pharmaceutical Corporation has commenced marketing and sales of its gel formulation of hyaluronan [‘L.A.M. IPM Wound Gel’] in the US. 1 The product is indicated for the management of serious skin ulcers. Escitalopram [‘Lexapro’; Forest Laboratories] has been approved by the US FDA for the treatment of major depressive disorder. 2 Roche’s granisetron [‘Kytril’] injection has been approved by the FDA for use in a new indication, the prevention and treatment of postoperative nausea and vomiting. 3 The product is already approved in the US for chemotherapy- and radiation therapy-induced nausea and vomiting. Valsartan [‘Diovan’; Novartis] has been granted FDA approval for use in a new indication, the treatment of heart failure in patients who are intolerant of ACE inhibitor therapy. 4 The product is already approved in the US for use in the treatment of hypertension. The FDA has issued an approvable letter for the use of atomoxetine [‘Strattera’; Eli Lilly and Company] in the treatment of children, adolescents and adult patients with attention-deficit hyperactivity disorder. 5 Roche and Trimeris have announced that physician enrolment in the US Early Access Program for enfuvirtide [‘Fuzeon’] will make the product available in the near term for a limited number of additional patients with advanced HIV infection. 6 1. LAM Pharmaceutical Corp. L.A.M. Commences Sales Today of Its Breakthrough Diabetic Ulcer Product L.A.M. IPM Wound Gel(TM). Media Release : 15 Aug 2002. Available from: URL: http://www.lampharm.com. 2. Forest Laboratories Inc. Lexapro(TM), The Single-Isomer of Celexa(TM), Receives FDA Approval For the Treatment of Major Depression. Media Release : 15 Aug 2002. Available from: URL: http://www.frx.com. 3. Roche. FDA Approves Kytril For The Prevention and Treatment of Post- Operative Nausea and Vomiting. Media Release : 19 Aug 2002. Available from: URL: http://www.rocheusa.com. 4. Novartis Pharmaceuticals Corporation. FDA Approves Blood Pressure Treatment Diovan(R) (valsartan) for Heart Failure. Media Release : 14 Aug 2002. Available from: URL: http://www.pharma.us.novartis.com. 5. Eli Lilly and Company. FDA Issues Approvable Letter for StratteraTM Media Release : 14 Aug 2002. Available from: URL: http://www.lilly.com. 6. Roche, et al. Roche and Trimeris Open Physician Enrollment For Fuzeon(TM) U.S. Early Access Program. Media Release : 16 Aug 2002. Available from: URL: http://www.rocheusa.com. 800888524 1 Inpharma 24 Aug 2002 No. 1352 1173-8324/10/1352-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1352 - 24 Aug 2002

Market news from the USLAM Pharmaceutical Corporation has commenced

marketing and sales of its gel formulation of hyaluronan[‘L.A.M. IPM Wound Gel’] in the US.1 The product isindicated for the management of serious skin ulcers.

Escitalopram [‘Lexapro’; Forest Laboratories] hasbeen approved by the US FDA for the treatment of majordepressive disorder.2

Roche’s granisetron [‘Kytril’] injection has beenapproved by the FDA for use in a new indication, theprevention and treatment of postoperative nausea andvomiting.3 The product is already approved in the US forchemotherapy- and radiation therapy-induced nauseaand vomiting.

Valsartan [‘Diovan’; Novartis] has been granted FDAapproval for use in a new indication, the treatment ofheart failure in patients who are intolerant of ACEinhibitor therapy.4 The product is already approved inthe US for use in the treatment of hypertension.

The FDA has issued an approvable letter for the use ofatomoxetine [‘Strattera’; Eli Lilly and Company] in thetreatment of children, adolescents and adult patientswith attention-deficit hyperactivity disorder.5

Roche and Trimeris have announced that physicianenrolment in the US Early Access Program forenfuvirtide [‘Fuzeon’] will make the product available inthe near term for a limited number of additional patientswith advanced HIV infection.6

1. LAM Pharmaceutical Corp. L.A.M. Commences Sales Today of ItsBreakthrough Diabetic Ulcer Product L.A.M. IPM Wound Gel(TM). MediaRelease : 15 Aug 2002. Available from: URL: http://www.lampharm.com.

2. Forest Laboratories Inc. Lexapro(TM), The Single-Isomer of Celexa(TM),Receives FDA Approval For the Treatment of Major Depression. Media Release: 15 Aug 2002. Available from: URL: http://www.frx.com.

3. Roche. FDA Approves Kytril For The Prevention and Treatment of Post-Operative Nausea and Vomiting. Media Release : 19 Aug 2002. Available from:URL: http://www.rocheusa.com.

4. Novartis Pharmaceuticals Corporation. FDA Approves Blood PressureTreatment Diovan(R) (valsartan) for Heart Failure. Media Release : 14 Aug2002. Available from: URL: http://www.pharma.us.novartis.com.

5. Eli Lilly and Company. FDA Issues Approvable Letter for StratteraTM MediaRelease : 14 Aug 2002. Available from: URL: http://www.lilly.com.

6. Roche, et al. Roche and Trimeris Open Physician Enrollment For Fuzeon(TM)U.S. Early Access Program. Media Release : 16 Aug 2002. Available from:URL: http://www.rocheusa.com.

800888524