Navigation Links
Charleston Laboratories, Inc. Announces Successful Completion of Pre-IND Meeting on New Migraine Treatment CL-H1T
Date:7/23/2013

CHARLESTON, S.C., July 23, 2013 /PRNewswire/ -- Charleston Laboratories, Inc., an emerging specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting related to opioid analgesics and other pain associated disease states, announced today the completion of its scheduled Pre-IND meeting with the U.S Food and Drug Administration (FDA) for the proposed Investigational New Drug, CL-H1T, as a novel treatment for patients who suffer from migraine pain and migraine induced nausea or vomiting.   

"The Pre-IND meeting with FDA's Division of Neurology Products (DNP) was positive and productive," said Mr. John Ameling, Vice President of Regulatory Affairs at Charleston. "The questions we raised in the Briefing Document were answered and clarified in the meeting. I am confident that Charleston will be able to conduct the Drug Development Program that DNP agreed to and submit an approvable a 505 (b) (2) New Drug Application."  

"From a drug development standpoint, the information we received from FDA during our Pre-IND meeting will facilitate our ability to complete our proposed program on CL-H1T" said Dr. Bill Kozarek, Charleston's Vice President of Product Development.  "I am very excited to advance the CL-H1T program to demonstrate significant benefits for patients who suffer from migraines, relieving pain and reducing or eliminating nausea and vomiting."

About Charleston Laboratories, Inc.

Charleston Laboratories, Inc. is a specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting, the two most burdensome side effects related to opioid analgesics and other pain associated disea
'/>"/>

SOURCE Charleston Laboratories, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. FDA Grants Charleston Laboratories, Inc. Request for Pre-IND Meeting on New Migraine Treatment
2. Charleston Laboratories, Inc. Begins Enrollment for CL-108 Phase 3 Clinical Trial
3. Charleston Laboratories, Inc. beginnt mit klinischer Phase 3-Studie für CL-108
4. Clontech Laboratories, Inc. Partners With Rubicon Genomics To Increase Speed And Efficiency Of Sample Preparation For RNA Sequencing
5. Besins Healthcare, Shin Nippon Biomedical Laboratories, Ltd Announce Delivery Technology Licensing Agreement for Intranasal Progesterone
6. Antigen Laboratories, Inc. to be Acquired by Ares Life Sciences
7. Positive Data, Pipeline Improvements & Market Expansion - Research Report on Abbott Laboratories, Stryker Corporation, St. Jude Medical, Cardiovascular Systems and MAKO Surgical
8. Abuse Deterrent Medicines Developer Pisgah Laboratories, Inc. Wins Top 5 Technologies Award from CLAAD
9. Abuse-Deterrent Medication Developer, Pisgah Laboratories, Achieves Top 5 Technologies Ranking
10. Pisgah Laboratories, Inc. Scores a Triple Play in the World Series Against Prescription Drug Abuse
11. IncellDx, Inc. Announces an Agreement with BioReference Laboratories, Inc. to Conduct a 10,000 Sample Study Using a Slideless Pap Smear
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... A lot of discussion in the medical community revolves ... injuries, or conditions. As medical science advances, doctors and surgeons ... that they consider to be more cutting edge. Yet, when ... method of treatment that stands out as the best solution ...
(Date:1/23/2015)... WASHINGTON , Jan. 23, 2015  A new analysis ... Part D 2015 enrollment data shows that 81 percent ... convenient access and extra discounts at certain pharmacies. The ... "Preferred pharmacy plans are now the foundation of ...
(Date:1/23/2015)... a third of reproductive-aged women enrolled in Medicaid, and more ... prescription for an opioid pain medication each year during 2008-2012, ... Weekly Report (MMWR). Opioids are typically prescribed ... They are also found in some prescription cough medications. The ...
Breaking Medicine Technology:No One-Size-Fits-All Remedy for Hernia Correction 2New Analysis: 81 Percent of Medicare Part D Seniors Choose "Preferred Pharmacy" Plans in 2015 2Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3
... Va., Oct. 27, 2011   FHSSA counts its ... organization (originally known as the Foundation for Hospices ... 90 partnerships between US hospice programs and organizations ... provide technical assistance, support and friendship.  They are ...
... R.I., Oct. 27, 2011 MEDfx ... power of connected healthcare in partnership with federal ... Lifetime Electronic Records (VLER) initiative for veterans and ... medical records for veterans and military personnel and ...
Cached Medicine Technology:FHSSA Launches New Campaign to Partner US Hospices with Programs in Sub-Saharan Africa 2MEDfx Demonstrates Potential of Connected Healthcare by Enabling Military and Civilian Medical Professionals to Securely Access Records, Improve Care Coordination 2
(Date:1/22/2015)... VogueQueen is a seasoned and trusted leader who ... are thrilled to have it lead the wedding dress industry ... of prom dresses for the global market. , “The CEO ... and he focuses on continuing the goal of operational excellence ...
(Date:1/22/2015)... AngelWeddingDress, the premier women’s dress supplier, has recently ... View website of AngelWeddingDress.com to find more details. ... online for a bridal party. AngelWeddingDress offers a variety ... Its maternity wedding dresses are specially designed for 2015. ...
(Date:1/22/2015)... Thousand of GranuFlo lawsuits ( http://www.granuflolawsuit2014.com/ ... GranuFlo and NaturaLyte dialysis concentrates continue to move forward ... Court, District of Massachusetts, Bernstein Liebhard LLP reports. According ... remanded a case filed by the state of Louisiana ...
(Date:1/22/2015)... Plainsboro, NJ (PRWEB) January 22, 2015 ... advocate and keynote speaker at the upcoming 32nd ... by ACCME-accredited Physicians’ Education Resource®, LLC (PER®) , ... breast would have gone undetected if she had not ...
(Date:1/22/2015)... IsoComforter, Inc. has introduced the most innovative ... design to treat specific body parts and muscle groups. , ... easy to use patented cold therapy machine with the innovative ... and muscle injuries. IsoComforter has become the industry leader ...
Breaking Medicine News(10 mins):Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:IsoComforter Introduces Best of Class Cold Therapy Product to the Worldwide Market 2
... in the recent past have argued about the implications of ... manage menopausal symptoms. A new study, however, has gone further ... the risk of developing breast cancer// if they consumed alcoholic ... their alcohol consumption pattern and on whether they were on ...
... to prevent mix-ups over identification of newborn babies. The ... has been introduced in the maternity ward of La ... babies are born, their fingerprints, and those of their// ... baby wear on their wrists. The barcodes also contain ...
... The Chairman and Managing Director of Eli Lilly and Co., ... price cut in the company's human insulin product 'Huminsulin', that ... the market by the end of this year. He added ... growing use of human insulin products and the phasing out ...
... survival on planet earth. Every one of us knows and ... how many of us know that the continuous //tension of ... a 24 hour period? According to a new study by ... be long-term effects on heart health. ,The study which ...
... published in the Experimental Eye Research journal cautioned that Monosodium ... foods could result in vision loss due to retina// injury. ... a chemical that sends signals between nerve cells. ... that were fed with diets high in MSG over a ...
... disorder that affects many systems of the body, called ... of faulty cell communication. This syndrome is said to ... and fingers and can also cause hearing loss, heart ... studied the genetic samples and medical histories from 17 ...
Cached Medicine News:Health News:Women on HRT should avoid alcohol 2Health News:Unhappy relationships could result in more than just heart breaks! 2Health News:Gene connected to Multi-System disorder discovered 2
... Electro-4 design allows "Four gels in one tank" ... to run 200 samples or more in one ... horizontal gels. To ensure even migration, the electrode ... gels being run. Ideal for high throughput procedures, ...
... be used for: Analytical Protein and ... SDS-PAGE gels IEF in ultrathin PAGE ... Protein and Peptide Separation: Non-denaturating PAGE ... Agarose Ampholyte Gels (Z64,071-9& Z64,075-1) Molecular ...
... set up and safe to use, the Gel ... casting and running agarose gels. The unit is ... direct-connect power supply eliminates a tangled mess of ... space. Designed for safety and convenience, the power ...
... electrophoresis system is designed for very fast and ... gels. This system allows the user to fast ... of high quality. Complete system with : 1 ... Maker Stands, (4) 52 x 60 mm Trays, ...
Medicine Products: