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Events
2017
2016
2015
2014
2013
2010
2009
2007
10/17/2017
Charleston Laboratories, Inc. Resubmits NDA for
CL-108
08/31/2017
Charleston Laboratories, Inc. Reacquires Rights to Novel Investigational Treatment CL-108, for Acute Pain and Opioid-Induced Nausea and
Vomiting
02/15/2017
Charleston Laboratories, Inc. Announces Senior Global Regulatory
Hire
02/03/2017
Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Receive Complete Response Letter from FDA for New Drug Application for CL-108 (hydrocodone, acetaminophen, promethazine) Tablets for Oral
Use
01/26/2017
Charleston Laboratories, Inc. Announces Formation of U.S. Commercial
Subsidiary
01/24/2017
Charleston Laboratories, Inc. Expands Senior Management Team with Two Key Appointments in Core Business Areas of Medical &
Commercialization
06/13/2016
Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce FDA Acceptance of New Drug Application (NDA) for
CL-108
05/11/2016
Charleston Laboratories, Inc. Announces Presentations at the Annual Scientific Meeting of the American Pain
Society
01/20/2016
Governor Scott Announces Charleston Laboratories, Inc. Expansion Will Create 25 New
Jobs
01/20/2016
The Business Development Board of Palm Beach Plays Key Role in Charleston Laboratories, Inc.
Expansion
10/29/2015
Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce Phase 3 Study of CL-108 Met Primary
Endpoints
08/20/2015
Charleston Laboratories, Inc. Announces Completion of a Second Phase 3 Clinical Trial on its Lead Product, CL-108, and the Appointment of Dr. Raymond Dionne to its Scientific Advisory
Board
08/03/2015
Charleston Laboratories, Inc. Initiates Patient Enrollment in a Phase 1 Study of Charleston’s Second Product,
CL-H1T
05/13/2015
Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce Three Poster Presentations at American Pain Society Annual
Meeting
04/06/2015
Charleston Laboratories, Inc. Completes Patient Enrollment in a Phase
3
03/12/2015
Charleston Laboratories, Inc. & Daiichi Sankyo, Inc. Announce Completion of a Pharmacokinetics Study on
CL-108
11/20/2014
Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Initiate Two Phase 3 Clinical Trials on Charleston’s Lead Product,
CL-108
10/09/2014
Prescription for
Success
09/09/2014
Charleston Laboratories, Inc. Announces Key Clinical Updates for Novel
Drugs
08/07/2014
Charleston Laboratories and Daiichi Sankyo Announce Collaboration to Develop and Commercialize Novel, Fixed-Dose Combination Hydrocodone Products for Pain and Opioid-Induced Nausea and Vomiting (OINV) in the
US
05/08/2014
Charleston Laboratories, Inc., Bolsters Senior Management
Team
10/29/2013
Strong Efficacy Data Prompt Charleston Laboratories to Halt Phase 3 Study of CL-108 in Patients with Moderate to Severe Acute
Pain
10/09/2013
Charleston Laboratories, Inc. Announces Research Collaboration with Stanford
University
07/23/2013
Charleston Laboratories, Inc Successfully Completes Pre-IND Meeting on New Migraine
Treatment
04/16/2013
FDA Grants Charleston Laboratories, Inc. Request for Pre-IND Meeting on New Migraine
Treatment
01/28/2013
Charleston Laboratories, Inc. Begins Enrollment for CL-108 Phase 3 Clinical
Trial
11/02/2010
Charleston Laboratories, Inc. Awarded a Qualifying Therapeutic Discovery Project
Grant
05/18/2009
Charleston Laboratories, Inc. Completes Exploratory Bioequivalence Study of
CL-108
02/12/2009
Charleston Conducts Evaluation of an Opioid Symptoms
Questionnaire
02/02/2009
Charleston Completes Preliminary Research on Nausea-Prone Questionnaire
(NPQ)
01/12/2009
Charleston Labs begins Bioequivalence Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of
CL-108
11/08/2007
Charleston completes successful Type B, Pre-IND meeting with FDA’s Division of Anesthesia, Analgesia and Rheumatology Products on November 8, 2007, held at FDA’s Silver Spring, Maryland
offices.
