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:
(Date:7/11/2014)... 2014 , Not for release, publication ... from any jurisdiction where to do so would constitute a ... Shire plc ("Shire" or the "Company") (LSE: SHP, NASDAQ: ... confirms it has held a meeting with representatives of AbbVie. ... the prior agreement or approval of AbbVie. A ...
(Date:7/11/2014)... 2014 BCC Research ( http://www.bccresearch.com ) ... CHAIN REACTION (PCR) TECHNOLOGY: GLOBAL MARKETS , the global ... nearly $140 billion in 2013. This is estimated to ... compound annual growth rate (CAGR) of 28.6%. , New ... and exciting possibilities within the broader PCR field. The ...
(Date:7/11/2014)... /CNW/ - Sunovion Pharmaceuticals Canada Inc. (Sunovion) today announced ... for use as a once-daily adjunctive therapy for the ... are not satisfactorily controlled with conventional therapy.  APTIOM TM ... 18 years of age. Epilepsy is ... to Epilepsy Canada, it affects 0.6% of the population ...
(Date:7/11/2014)... 2014 Cayenne Medical, Inc., a ... the soft tissue reconstruction segment, announced the worldwide ... surgeries involving the shoulder and extremities. The SureLock ... inserter-controlled deployment method. The unique delivery eliminates manual ... pull-out, or anchor displacement (also commonly know as ...
Breaking Biology Technology:Shire plc - Statement re: Media Speculation 2Global Market for Digital Polymerase Chain Reaction Technology to Reach $490 Billion by 2018; Equipment Sector Accounts for the Fastest Growing Segment With 33% CAGR 2Global Market for Digital Polymerase Chain Reaction Technology to Reach $490 Billion by 2018; Equipment Sector Accounts for the Fastest Growing Segment With 33% CAGR 3Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Approval of APTIOM(TM) (eslicarbazepine acetate) as a Once-Daily Adjunctive Treatment for Partial-Onset Seizures in Patients with Epilepsy 2Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Approval of APTIOM(TM) (eslicarbazepine acetate) as a Once-Daily Adjunctive Treatment for Partial-Onset Seizures in Patients with Epilepsy 3Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Approval of APTIOM(TM) (eslicarbazepine acetate) as a Once-Daily Adjunctive Treatment for Partial-Onset Seizures in Patients with Epilepsy 4Cayenne Medical Launches SureLock™ All-Suture Anchor System for Shoulder and Extremity Surgery 2Cayenne Medical Launches SureLock™ All-Suture Anchor System for Shoulder and Extremity Surgery 3
... to use anti-theft software Rockwell signs agreement ... for data imaging Wisconsin bankers ... of Wisconsin will be the first state banking association ... announced on Wednesday at BAI's Retail Delivery Conference and Expo ...
... place inside the Monona Terrace. (Jason Stitt/WTN) Angel ... of Wisconsins continually evolving technology culture at the ... and Wednesday at the Monona Terrace. , ,Biotech companies ... panels studied the future of the states industry. , ...
... Wisconsin Institute for Discovery It was inevitable that ... interdisciplinary research center on the UW-Madison campus would be ... a $3 billion, 10-year initiative to fund human embryonic ... research is a sizable part of what will happen ...
Cached Biology Technology:Life-sciences conference showcases capital ideas of Wisconsin 2Life-sciences conference showcases capital ideas of Wisconsin 3Doyles proposal is about more than keeping pace with California 2Doyles proposal is about more than keeping pace with California 3
(Date:7/11/2014)... Social animals often develop relationships with other group members ... In wild chacma baboons the strategy for grooming activities ... are just published in the scientific journal Biology ... of baboons is not practiced without ulterior motives. To ... for the individual, while grooming another individual can provide ...
(Date:7/11/2014)... July 11, 2014 Researchers have pioneered a ... The new technology, called Virtual Finger, allows scientists ... like neurons and synapses using the flat surface ... makes 3D imaging studies orders of magnitude more ... unprecedented level across many areas of experimental biology. ...
(Date:7/11/2014)... marginal division of the striatum is also involved ... degree of substance P in the striatal marginal ... and his team, College of Biophotonics, South China ... substance P receptor, neurokinin 1 was highly expressed ... normal rats. Unilateral or bilateral injection of an ...
Breaking Biology News(10 mins):Baboons groom early in the day to get benefits later 2Virtual finger enables scientists to navigate and analyze complex 3D images 2
... - an antibacterial chemical found in toothpaste and other ... allergy development in children. This comes from the Norwegian ... Institute of Public Health is involved. Similar results are ... in use for decades, but was recently associated with ...
... is when a horse shakes or jerks its head ... similarities between facial pain syndromes in people, most notably ... has been made towards both diagnosing and treating the ... unknown and further research is needed. ...
... in combination with other measures, could significantly improve numbers ... a fish modelling study has found., Scientists working at ... Secretariat of the Pacific Community (SPC, Noumea, New Caledonia) ... that a network of marine zones in the Pacific ...
Cached Biology News:Triclosan in cosmetics and personal care products can increase allergy risk 2Study investigates headshaking in horses 2Pacific fishing zones -- lifeline for overfished tuna? 2
...
... The Jouan MSC series of ... comfortable working conditions and certification to ... automatic regulation ensures that the cabinets ... working conditions. Natural lighting, low noise ...
... are designed to create the ideal environment for ... to 99.9C) , Variable speed control (10 ... whether it be for washing or hybridizing ... temperature inside the chamber, ,is situated above a ...
... specifically engineered for efficient drying down of ... glass cover and a post-trap with ammonia ... processing of samples in ammonium hydroxide., ... , Comes standard ...
Biology Products: