Navigation Links
QLT announces positive Health Canada decision on Aczone(R)
Date:6/6/2008

Blood testing requirements removed

VANCOUVER, June 6 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI; TSX: QLT) announced today that Health Canada has completed its review of QLT USA, Inc.'s labeling supplement (SNDS) for Aczone(R) and has removed the glucose-6-phosphate dehydrogenase (G6PD) screening and blood monitoring requirements.

"We are extremely pleased to report Health Canada's decision to remove the need for blood monitoring from the Aczone label," said Bob Butchofsky, President and Chief Executive Officer of QLT. "This positive review, along with the FDA's recent decision to also remove the need for blood monitoring from the Aczone label, validates our regulatory strategy, increases Aczone's commercial potential, and enhances the product's overall attractiveness to potential acquirers."

Aczone was originally approved by Health Canada in June 2006 with a similar label restriction as that required by the US Food and Drug Administration (FDA). The label called for all patients to undergo G6PD screening and for those patients with this enzyme deficiency, regular blood monitoring was required during Aczone treatment. On March 17, 2008 the Company announced that the FDA removed the G6PD screening and monitoring requirements based on a Phase IV clinical trial in 56 safety-evaluable G6PD-deficient patients. During a six-month period, patients were treated with both Aczone and the Aczone-vehicle (control group) in a cross-over design. Data was analyzed by third party clinical experts in dermatology and hematology who concluded that no clinically meaningful changes in safety-related parameters were observed in the trial.

Aczone, a prescription topical medicine for the treatment of acne vulgaris, is the only acne treatment to harness the potential of dapsone in a topical formulation to provide patients with a convenient and effective therapy. QLT USA owns worldwide marketing rights to Aczone.

About Aczone(R)
'/>"/>

SOURCE QLT Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. ETHICON, INC. Announces Revised Label For REGRANEX(R) (becaplermin) Gel 0.01%
2. Telik Announces Presentation and Webcast at Needham Biotechnology Conference
3. Biopure Announces MHRA Meeting Update
4. BioMarin Announces Program for ERT for Treatment of MPS IVA - Morquio A Syndrome
5. Millennium Biotechnologies Announces an Increased Annualized Purchase Commitment Totaling $5.8M from Provider Services, Inc.
6. American Oriental Bioengineering Announces that it Withdraws Convertible Preferred Stock Offering
7. Exelixis Announces June 5 Webcast of Conference Call Regarding Its $150 Million Funding Commitment from Deerfield Management
8. Synthetech Announces Fiscal 2008 Results
9. Immucor Announces Fiscal Year 2009 Revenue and Earnings Guidance
10. Martek Announces Second Quarter 2008 Financial Results
11. WWMR, Inc. Announces Launch of New Pain Clinic Monitor
Post Your Comments:
*Name:
*Comment:
*Email:
Breaking Biology News(10 mins):University of the Basque Country research on plankton at Urdaibai 2BIO-key(R) Selected as 2009 Industry Innovator in Biometrics by SC Magazine 2BIO-key(R) Selected as 2009 Industry Innovator in Biometrics by SC Magazine 3The impact of the diffusion of maize to the Southwestern United States 2Intelliject Inc Enters Into Licensing Agreement with sanofi aventis for U S Canada Rights to Novel Epinephrine Auto injector 6577 1Intelliject Inc Enters Into Licensing Agreement with sanofi aventis for U S Canada Rights to Novel Epinephrine Auto injector 6577 2Intelliject Inc Enters Into Licensing Agreement with sanofi aventis for U S Canada Rights to Novel Epinephrine Auto injector 6577 3Sanofi aventis U S and Intelliject Inc Sign Licensing Agreement for Novel Epinephrine Auto Injector in North America 6575 1Sanofi aventis U S and Intelliject Inc Sign Licensing Agreement for Novel Epinephrine Auto Injector in North America 6575 2Sanofi aventis U S and Intelliject Inc Sign Licensing Agreement for Novel Epinephrine Auto Injector in North America 6575 3New VeriLook 4 0 for Biometric Facial Recognition and MegaMatcher 3 1 for Multi biometric Applications Are Now Available 10913 1New VeriLook 4 0 for Biometric Facial Recognition and MegaMatcher 3 1 for Multi biometric Applications Are Now Available 10913 2New VeriLook 4 0 for Biometric Facial Recognition and MegaMatcher 3 1 for Multi biometric Applications Are Now Available 10913 3