Navigation Links
Solstice Neurosciences, Inc. Issues Corporate Response to FDA Early Communication
Date:2/8/2008

MALVERN, Pa., Feb. 8 /PRNewswire/ -- Safety of patients treated with Myobloc(R) (Botulinum Toxin Type B) Injectable Solution has always been of primary importance for Solstice Neurosciences, Inc. ("Solstice"). We support education and training of physicians in a number of ways regarding the proper use of this product as outlined in the prescribing information.

We maintain a rigorous and routine process for monitoring and reporting any adverse events to regulatory authorities in compliance with all applicable regulations.

Manufacturers of botulinum toxin products have recently submitted safety information to the FDA. In its review of this information and other available data, the Agency's posting of this Early Communication "does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue."

Solstice supports the FDA review of botulinum toxins and remains committed to providing FDA with any additional information needed.

About MYOBLOC

MYOBLOC was the first drug approved in the US to reduce the severity of abnormal head position and the neck pain associated with cervical dystonia. When injected into an affected muscle, botulinum toxin type B inhibits the release of the neurotransmitter, acetylcholine, at the motor nerve terminals to allow it to relax.

Regulatory approvals in the US, EU and Canada were based on the results from randomized, multi-center, double-blind, placebo-controlled studies in adult patients with cervical dystonia.

MYOBLOC is supplied as a ready-to-use, injectable solution in three single-dose vial sizes of 0.5 mL (2,500 U), 1.0 mL (5,000 U), and 2.0 mL (10,000 U). Unopened vials of MYOBLOC have demonstrated stability when stored at 2-8 degrees Celsius, and are approved for a 36-month shelf life in the EU, and a 48-month shelf-life in the US and Canada.

About Solstice Neurosciences, Inc.

Founded in 2004, Solstice Neurosciences, Inc. is a biopharmaceutical company focused on the development, manufacturing, sales and marketing of specialty products. Solstice's first product, MYOBLOC, represents the only botulinum toxin type B currently available to physicians and patients worldwide. MYOBLOC is sold in the United States and is approved in Canada. It is also distributed and sold in the EU as NeuroBloc. MYOBLOC is indicated for the treatment of patients with cervical dystonia (CD) to reduce the severity of abnormal head position and pain associated with CD. For more information about Solstice Neurosciences, Inc., visit http://www.solsticeneuro.com

Myobloc(R) is a registered trademark of Solstice Neurosciences, Inc.


'/>"/>
SOURCE Solstice Neurosciences, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Dennis L. Smith Appointed President and Chief Executive Officer of Solstice Neurosciences, Inc.
2. Dennis L. Smith Appointed Executive Chairman to Board of Directors of Solstice Neurosciences, Inc.
3. Intellect Neurosciences, Inc. Obtains Validation of European Patent for Alzheimers Vaccine in 19 Countries
4. Intellect Neurosciences, Inc. to Present Data on Alzheimers Vaccine at 13th International Congress of Immunology Conference
5. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
6. Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/mL 10 and 30mL Multi-Dose Vials
7. FDA Issues Approvable Letter for LUVOX(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
8. Maryland Stem Cell Commission Issues Nationwide Request for Applications for New Post-Doctoral Fellowship Grants
9. CCPM Issues Statement on FDAs GIVE Initiative
10. Symmetry Medical Discloses Accounting Issues at Sheffield, UK Operating Unit and Possible Restatement
11. CalbaTech Issues Update; Beginning Training for Adult Stem Cell Collections in Atlanta
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/13/2017)... ... January 13, 2017 , ... FireflySci ... it has found among its diverse customer base. The latest entry in this ... brands electroporators including BTX and Bio-Rad. FireflySci is introducing three distinct varieties including ...
(Date:1/12/2017)... ... January 12, 2017 , ... Huffman Engineering, Inc. , ... who will work in the company’s Lincoln office as a chemical engineer. In ... control systems for customers in the life science manufacturing and water/wastewater industries. , Prior ...
(Date:1/12/2017)... 2017 The report "Direct-Fed Microbials Market by Type (Lactic Acid Bacteria ... and Region - Global Forecast to 2022", published by MarketsandMarkets, the global market ... to reach USD 1,399.6 Million by 2022, at a CAGR of 6.96% from ... ... MarketsandMarkets Logo ...
(Date:1/11/2017)... ... January 11, 2017 , ... Photonics industry and STEM ... are commending the U.S. Congress and President Obama for their recognition of the ... the American Innovation and Competitiveness Act (AICA). , The language of the act ...
Breaking Biology Technology:
(Date:12/7/2016)... 2016   Veridium , a leader in ... new CEO James Stickland . Stickland, a ... experience, has served in senior executive roles for ... in expanding a pipeline of venture capital and ... recently served as managing director of U.K.-based fintech ...
(Date:12/6/2016)... Valencell , the leading innovator in ... a third consecutive year of triple digit growth for ... with a 360 percent increase in companies who have ... driven by sales of its wrist and ear Benchmark™ ... technology for hearables for fitness and healthcare applications. ...
(Date:12/5/2016)... -- The Office of Justice Programs, National Institute of ... or Replace Medico Legal Autopsies?" on NIJ.gov.  The ... forensic autopsies with postmortem X-ray computed tomography, commonly ... to recommendations made by The National Academy of ... a potential component of medicolegal death investigations. NIJ,s ...
Breaking Biology News(10 mins):