Navigation Links
FDA Issues Complete Response Letter for RISPERDAL(R) CONSTA(R) for the Adjunctive Maintenance Treatment of Bipolar Disorder
Date:2/10/2009

TITUSVILLE, N.J., Feb. 10 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that the Food and Drug Administration (FDA) has asked for additional information regarding the company's supplemental New Drug Application (sNDA) for RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Injection. The sNDA, submitted in April 2008, sought approval for RISPERDAL(R) CONSTA(R) for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with bipolar disorder who relapsed frequently.

The Agency's complete response outlined questions that need to be addressed prior to granting approval for the new indication, but did not request additional studies.

J&JPRD is currently evaluating the FDA's complete response letter and will work with the Agency to resolve any outstanding questions.

Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. It is often characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression), and affects 5.7 million, or 2.6 percent, of the American adult population in any given year.(1)

RISPERDAL(R) CONSTA(R) is marketed in the U.S. by Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by Alkermes, Inc. RISPERDAL(R) CONSTA(R) was initially approved for the treatment of schizophrenia in the U.S. in 2003 and is registered in more than 80 countries worldwide. Using Alkermes' proprietary Medisorb(R) drug-delivery technology, the RISPERDAL(R) CONSTA(R) formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to provide therapeutic blood levels of the drug in the blo
'/>"/>

SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Pharmos Issues Letter to Shareholders
2. MichBio Issues 2007/8 Michigan Life Sciences Directory and Resources Guide
3. HHS Issues First Department-Wide Report on Personalized Health Care
4. CalbaTech Issues Update; Beginning Training for Adult Stem Cell Collections in Atlanta
5. Symmetry Medical Discloses Accounting Issues at Sheffield, UK Operating Unit and Possible Restatement
6. CCPM Issues Statement on FDAs GIVE Initiative
7. Maryland Stem Cell Commission Issues Nationwide Request for Applications for New Post-Doctoral Fellowship Grants
8. 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)
9. Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/mL 10 and 30mL Multi-Dose Vials
10. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
11. Solstice Neurosciences, Inc. Issues Corporate Response to FDA Early Communication
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... (PRWEB) December 17, 2014 Gene ... that it has entered into a technology access ... (ADM) to apply DNA2.0’s proprietary protein engineering technology, ... process. , “We are extremely excited that the ... platform. This proprietary bioengineering technology has now ...
(Date:12/17/2014)... SOUTH SAN FRANCISCO, Calif. , Dec. 17, ... positive results of a Phase 2 study evaluating ... for the treatment of patients with severe, chronic ... the current standard of care, including topical steroids ... endpoint was percent change in Visual Analog Scale ...
(Date:12/15/2014)...  GlassesOff Inc. (OTCBB: GLSO) announced today the appointment ... director of the Company,s Board of Directors. ... its CEO until its acquisition by Stanley Black ... Recognized as the inventor of the first Wi-Fi-based Active ... -based RFID solutions focused on improving operational efficiency, safety ...
(Date:12/13/2014)... (PRWEB) December 12, 2014 Clarassance, a ... announced its new name: Therabron Therapeutics , Inc. ... and bronchioles (a type of structure in the lungs ... company’s mission to develop novel protein therapeutics for the ... directors decided to change the name to mark the ...
Breaking Biology Technology:ADM and DNA2.0 Enter Into Protein Engineering Technology Access and Service Agreement 2Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 2Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 3Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 4AeroScout Founder Joins GlassesOff's Board of Directors 2AeroScout Founder Joins GlassesOff's Board of Directors 3Maryland-based Biotech Company's Path Forward in Treating Respiratory Diseases Sparks Name Change 2
... -- (May 30, 2010) -- In a development that ... researchers from Rice University and the Technion-Israel Institute of ... quantities of one-atom-thick sheets of carbon called graphene. ... Nature Nanotechnology . When stacked together, graphene sheets ...
... ... a detailed “road map” defining all aspects of the future 110-acre Livermore Valley Open ... site planning, and real estate development planning, as well as maintenance and operations planning. ... San Francisco, ...
... May 28 BioSpace.com is putting the nation,s Middle-Atlantic region on ... (Logo:   http://www.newscom.com/cgi-bin/prnh/20040907/CLTU006LOGO ) , ... The leading career Web site for the life sciences ... edition and highlighting multiple companies within Washington D.C. , Delaware , ...
Cached Biology Technology:Liquid method: pure graphene production 2Flad Architects Awarded Livermore Valley Open Campus Master Plan 2BioSpace Launches 10th Campaign Map for the Mid-Atlantic 2BioSpace Launches 10th Campaign Map for the Mid-Atlantic 3
(Date:11/11/2014)... Nov. 11, 2014  Forensicon, Inc., a ... pleased to announce the promotion of Yaniv Schiff ... Digital Forensics. In Schiff,s new role as Director, he ... of digital forensics examiners and provide leadership within the ... - http://photos.prnewswire.com/prnh/20141110/157719 Schiff joined ...
(Date:11/7/2014)... professor, biomedical engineering, in the Grove School of ... have identified a molecule that could lead to ... forms of breast cancer. , Triple negative breast ... to aggressive proliferation and metastasis and a lack ... discovered the overexpression of intercellular adhesion molecule-1 (ICAM-1) ...
(Date:11/7/2014)... November 6, 2014 Leading Biometric companies ... mobile security revolutionizing online transactions.  Companies in focus today are: ... (NYSE: BABA ), Google Inc. (NASDAQ: ... Inc. (NASDAQ: EBAY ) and MasterCard Inc. (NYSE: ... and NXTDW), a biometric authentication company focused on the growing ...
Breaking Biology News(10 mins):Yaniv Schiff Promoted to Director of Digital Forensics at Forensicon, Inc. 2Universal Authentication Methods Provide More Secure Operations for Biometrics Devices - Company Joins FIDO Alliance for Consumer Protection 2Universal Authentication Methods Provide More Secure Operations for Biometrics Devices - Company Joins FIDO Alliance for Consumer Protection 3Universal Authentication Methods Provide More Secure Operations for Biometrics Devices - Company Joins FIDO Alliance for Consumer Protection 4Universal Authentication Methods Provide More Secure Operations for Biometrics Devices - Company Joins FIDO Alliance for Consumer Protection 5Universal Authentication Methods Provide More Secure Operations for Biometrics Devices - Company Joins FIDO Alliance for Consumer Protection 6
... times stronger than steel, weighs one-sixth as much and can ... The answer is a carbon nanotube -- and a new ... nanomaterials snap when subjected to ultrasonic vibrations in a liquid. ... but not bend, does not hold at the micro- and ...
... The Philippines, scientists from 21 research institutions from Germany, ... several concerns on the future of the rice ecosystems ... the framework of the international project LEGATO ... arising from various aspects of global change. "Threats ...
... used metal complexes to modify peptide hormones. In the ... report for the first time on the three-dimensional structure ... have laid the molecular foundation for the development of ... of Chemistry and Biochemistry at the Ruhr-University. The team ...
Cached Biology News:Tiny bubbles snap carbon nanotubes like twigs 2Tiny bubbles snap carbon nanotubes like twigs 3Sustainability of rice landscapes in South East Asia threatened 2A new avenue to better medicines: Metal-peptide complexes 2
... is a high performance spectral scanning ... incubator. With the advanced SkanIt Software ... for drug discovery assay development. Varioskan ... intensity, time-resolved fluorescence and photometric assays ...
Strip Removal Tool 25/Box...
Oven mesh sheets, large, 23 x 23cm, pack of 5...
... Lambda Protein Phosphatase ... Mn2+-dependent protein phosphatase with ... threonine and tyrosine residues. ... amino-acid product of the ...
Biology Products: