Navigation Links
Topaz Pharmaceuticals Announces New Drug Application for the Treatment of Head Lice Accepted by FDA
Date:6/7/2011

HORSHAM, Pa., June 7, 2011 /PRNewswire/ -- Topaz Pharmaceuticals Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for the use of ivermectin topical cream as a treatment for head lice infestations in children and adults.  

"This filing represents the transition of the Company from the development phase as we are now preparing to commercialize our lead product candidate," said Robert Radie, chief executive officer and president of Topaz.  "Current treatment options are limited by one or more of safety, efficacy and convenience issues.  We believe there is an unmet need to provide a new option for the more than six million people, mostly school-aged children, who are impacted by lice each year in the United States.  With the potential for our lead product to be the first ivermectin formulation for the treatment of head lice, we believe we can improve the experience individuals and their families have during a head lice infestation."  

Topaz submitted the NDA for ivermectin cream to the FDA on April 7, 2011. Acceptance of the NDA for review represents the FDA's determination that the application is sufficiently complete to permit a substantive review of the data. The acceptance of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of ivermectin cream. Under PDUFA (Prescription Drug User Fee Act) it is the FDA's goal to review and act on this NDA by February 7, 2012.

The NDA submitted by Topaz included data from two randomized double blind phase 3 clinical trials that compared 0.5% ivermectin cream with a vehicle control (placebo).  Ivermectin topical cream or placebo was dispensed to clinical trial participants six months of age and older for application to dry hair and scalp followed by a rinsing after 10 minutes.  The primary efficacy
'/>"/>

SOURCE Topaz Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Topaz Pharmaceuticals Names Dr. Mark Strobeck Chief Business Officer
2. Topaz Pharmaceuticals Announces Completion of Pivotal Phase 3 Trials of Ivermectin Topical Cream
3. Topaz Pharmaceuticals Names Bob Radie Chief Executive Officer
4. TOPAZ Technologies and ML Weekes & Company Announce Partnership
5. Shareholder Class Action Filed Against SciClone Pharmaceuticals, Inc. by the Law Firm of Barroway Topaz Kessler Meltzer & Check, LLP
6. Topaz Pharmaceuticals Announces Positive Data from Topical Ivermectin Trials Presented at Society of Pediatric Dermatology
7. TOPAZ Technologies and Tecniplast USA Launch RFID Mobile Census
8. Shareholder Class Action Filed Against Rigel Pharmaceuticals, Inc. by the Law Firm of Barroway Topaz Kessler Meltzer & Check, LLP
9. Shareholder Class Action Filed Against Vertex Pharmaceuticals Incorporated by the Law Firm of Schiffrin Barroway Topaz & Kessler, LLP
10. Schiffrin Barroway Topaz & Kessler, LLP and Janet Jenner & Suggs, LLC Comment on Conagra Advisory Regarding Pot Pies Linked to Salmonella Outbreak
11. Aeolus Pharmaceuticals, Inc. Presentation Now Available for On-demand Viewing at RetailInvestorConferences.com
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/3/2015)... -- Ortho Clinical Diagnostics (OCD) today announced that ... and Communications Officer, effective immediately. As the newest member ... the company,s worldwide corporate brand and communication strategies as ... company by adding sites in countries outside the U.S. ... Dr. Martin Madaus . Since becoming ...
(Date:8/3/2015)... Global physiotherapy equipments ... 24.7 billion by 2022, according to a new ... of neurological and musculoskeletal disorders are expected to ... period. The presence of efficient and effective therapies ... technologies coupled with implementation of favorable government policies ...
(Date:8/3/2015)... ANGELES, Aug. 3, 2015  CytRx Corporation (NASDAQ: ... in oncology, today reported financial results for the three ... overview of recent accomplishments and upcoming milestones for its ... 2015 has been very productive for CytRx. Enrollment in ... aldoxorubicin in soft tissue sarcoma (STS) continues on track ...
Breaking Medicine Technology:Ortho Clinical Diagnostics Appoints Kristie Bouryal Chief Corporate Brand and Communications Officer 2Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 2Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 3Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 4Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 5CytRx Reports 2015 Second Quarter Financial Results 2CytRx Reports 2015 Second Quarter Financial Results 3CytRx Reports 2015 Second Quarter Financial Results 4CytRx Reports 2015 Second Quarter Financial Results 5CytRx Reports 2015 Second Quarter Financial Results 6CytRx Reports 2015 Second Quarter Financial Results 7CytRx Reports 2015 Second Quarter Financial Results 8CytRx Reports 2015 Second Quarter Financial Results 9CytRx Reports 2015 Second Quarter Financial Results 10CytRx Reports 2015 Second Quarter Financial Results 11CytRx Reports 2015 Second Quarter Financial Results 12CytRx Reports 2015 Second Quarter Financial Results 13CytRx Reports 2015 Second Quarter Financial Results 14
... Dec. 4 Long-term data published in,EuroIntervention showed ... (MVA),after repair with the MitraClip(R) system to correct ... mitral stenosis. Additionally,with two years of follow-up, none ... surgery for mitral stenosis. At 12 months no,important ...
... newly diagnosed patients with a life-threatening type of leukemia to be ... , - Exjade results at ASH to show benefits ... damage key organs , , - ... to report on optimal post-surgery treatment strategy, Femara vs. tamoxifen , ...
Cached Medicine Technology:Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System 2Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System 3Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System 4More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 2More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 3More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 4More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 5More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 6More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 7More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 8More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 9More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 10More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 11More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 12More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 13More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 14More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 15More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 16More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 17More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 18More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 19More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 20More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 21More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 22
(Date:8/3/2015)... Irvine, CA (PRWEB) , ... August 03, 2015 ... ... for Hispanic Health notes that while an overwhelming number of Hispanics believe ... health. , The overwhelming 70 percent of participants queried said making diet changes ...
(Date:8/3/2015)... , ... August 03, 2015 , ... ... of its industry-defining contract lifecycle management solution, as well as announced the date ... increase the speed and ease of contract management tasks as well as enhancements ...
(Date:8/3/2015)... OR (PRWEB) , ... August 03, 2015 , ... ... California’s Modoc National Forest, to Ahjumawi Lava Springs, California’s northernmost and among its ... California’s largest untapped ground water aquifers, whose main outflow is at Ahjumawi Lava ...
(Date:8/3/2015)... ... August 03, 2015 , ... Illinois Health & Science ... 31. , The acquisition includes all of IBAM NA’s cyclotron sites and research ... both, a robust regionally located business, as well as a large manufacturing hub in ...
(Date:8/3/2015)... ... , ... Foot and Ankle Specialists of the Mid-Atlantic (FASMA) is ... practice in the Mid-Atlantic region – and the second largest in the United States ... , Dr. Hetal Kathrotiya-Mago is a Maryland native. She grew up in Laurel, Maryland. ...
Breaking Medicine News(10 mins):Health News:Hispanics More Likely to Struggle with Misinformation About Diabetes 2Health News:Hispanics More Likely to Struggle with Misinformation About Diabetes 3Health News:Hispanics More Likely to Struggle with Misinformation About Diabetes 4Health News:Novatus Unveils Milestone Software Release 2Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 2Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 3Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 4Health News:Illinois Health & Science Expands Nuclear Medicine Footprint With Purchase of IBA Molecular North America, Inc. 2Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 2Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 3Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 4
... less likely, women more, to develop the disorder, study finds, ... a neurological disorder characterized by a strong urge to move ... than others, a new U.S. study has found. , Researchers ... About 12 percent of those who were black, compared with ...
... National Laboratory are collaborating on a study to determine ... the space shuttle can be used to predict tissue ... therapy. The study is examining the utility of ... from the study are being displayed during the American ...
... currently under development by the University of Pittsburgh School ... after radiation exposure, according to a study by Pitt ... p.m. today during the American Society for Radiation Oncology ... is a free-radical scavenger targeted to the mitochondria, the ...
... in packaging, paper and exposures were evident in most ... -- Chemicals used in food packaging, paper and textile ... researchers have found. , Previous studies have found that ... most people. In this new study, a team at ...
... Skin Cell is the Star Avatar at KidsSkinHealth.org , SCHAUMBURG, ... by dermatologists lets kids learn how to practice ... , greasy hair, a poison ivy rash ... Cell,s Life," is just one of the many features on the American ...
... 2 Blue Cross Blue Shield of Michigan and ... innovative oncology treatment initiative aimed at enhancing the quality ... , OPR, a statewide physician organization comprised ... working with oncology leaders from across Michigan, as well ...
Cached Medicine News:Health News:Restless Legs May Vary by Race and Gender 2Health News:Adapting space-industry technology to treat breast cancer 2Health News:Adapting space-industry technology to treat breast cancer 3Health News:Household Chemicals May Affect Cholesterol Levels 2Health News:Dermatologists Launch New Web Site and Game to Teach Kids about Healthy Skin, Hair and Nail Habits 2Health News:Dermatologists Launch New Web Site and Game to Teach Kids about Healthy Skin, Hair and Nail Habits 3Health News:Blue Cross Blue Shield of Michigan and Michigan Oncologists Launch Statewide Initiative to Create Cancer Guidelines 2Health News:Blue Cross Blue Shield of Michigan and Michigan Oncologists Launch Statewide Initiative to Create Cancer Guidelines 3
For surgical treatment, repair and irrigation of the nasolacrimal system. Stainless steel probes, 20G x 1 3/4in (.90 x 45cm) Silicone rod, length 13 3/4in (40cm), Diameter.032in (.80mm)...
For surgical treatment, repair and irrigation of the nasolacrimal system. Stainless steel probes, 23G x4 1/2in (.60mm x 11cm) Silicone tubing, length 14in (35cm), ID: .012in (.30mm) OD: .025in (.60mm...
IOL choppers for positioning intraocular lenses. Blunt tip avoids damage to intraocular lenses. For .20mm diameter holes and larger....
...
Medicine Products: