Navigation Links
FDA Accepts Tris Pharma's ANDA with Paragraph IV Certification for a Generic Equivalent to Delsym
Date:7/16/2009

SOUTH BRUNSWICK, N.J., July 16 /PRNewswire/ -- Tris Pharma, Inc., a drug delivery and specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 12-hour sustained release Dextromethorphan liquid suspension product prior to the expiration of a patent listed in the FDA's orange book for Reckitt Benckiser's Delsym product. Delsym, a leading OTC brand and the only FDA approved 12-hour liquid product for cough is different from most brands of cough medicine as the active ingredient is "time released" in liquid syrup. If approved, Tris Pharma's dextromethorphan polistirex suspension will be the generic version of Reckitt Benckiser's Delsym.

Tris Pharma's proposed dextromethorphan product is a LiquiXR(TM)( )formulation built on the Company's proprietary OralXR+(TM) platform, which allows Tris to formulate sustained release oral formulations that do not require patients to swallow a "pill." Other OralXR+ dosage forms include sustained release chewable tablets, orally disintegrating tablets, and film strips. Earlier this year, the FDA accepted for filing Tris Pharma's New Drug Applications for the first ever 24-hour sustained release oral liquid products.

Tris Pharma's ANDA seeking approval for a generic version of Delsym was filed earlier this year, and upon FDA's acceptance of the submission Tris notified the NDA holder and patent holder of its paragraph IV certification. Reckitt Benckiser filed suit against Tris on June 26, 2009, in the U.S. District Court for the District of New Jersey seeking to prevent Tris from commercializing its product prior to expiration of the Orange Book patent listed for Delsym, U.S. Patent 5,980,882. Reckitt Benckiser's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Tris Pha
'/>"/>

SOURCE Tris Pharma
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Victory Pharma, Inc. Announces FDA Accepts MGX006 NDA for Review
2. Specialty Hospitals of America Accepts First Patients in New Long Term Critical Care Hospital Located in South East Washington
3. FDA Accepts Final Section of NDA Filing for LUCASSIN(R)
4. NYSE Amex Accepts China Shenghuos Compliance Plan for Continued Listing
5. NYSE Amex LLC Accepts Plan of Compliance of The Quantum Group, Inc.
6. United States Patent and Trademark Office Accepts CoolTouch's Re-examination Request for Cynosure '873 Patent
7. NYSE Amex Accepts Interleukin Genetics Plan to Meet Continued Listing Standards
8. Gamma Pharmaceuticals Accepts PO From Leading St. Louis Missouri Distributor. Order Valued up to $850,000 Retail Market Value
9. FDA Accepts Nuvos Resubmission For Pennsaid(R)
10. ROXRO Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain
11. Andre Konski, M.D., M.B.A., Accepts Radiation Oncology Position at Wayne State University and the Karmanos Cancer Institute
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/3/2015)... ... ... will hopefully be getting a large donation of canned food items at the end ... making it their mission to collect as many canned items as possible. Donations do not ... as well. As part of the canned food drive, these local chiropractors will be donating ...
(Date:7/3/2015)... ... July 03, 2015 , ... Scientists at several top ... mesothelioma with even minimal asbestos exposure. Click here to read the complete story ... of Hawaii Cancer Center, Cedars Sinai Medical Center, and New York University exposed mice ...
(Date:7/3/2015)... ... July 03, 2015 , ... The Erie County ... 2015 at 1:00pm. The Association welcomed speaker C. Daniel McGillicuddy Esq. of William ... practical points of investigating these types of cases. , Each year, New York ...
(Date:7/3/2015)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... Director of its Frisco facility. , “We are pleased to announce that Dr. Manzanares ... Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Manzanares received ...
(Date:7/3/2015)... (PRWEB) , ... July 03, 2015 , ... The Celebrity ... or cocktail dresses similar to those of celebrities will have the opportunity to get ... at checkout. This ensures that people do not have to use coupon codes or ...
Breaking Medicine News(10 mins):Health News:Greenville Area AlignLife Offices to do a Thanksgiving in July Food Drive 2Health News:Greenville Area AlignLife Offices to do a Thanksgiving in July Food Drive 3Health News:Study Finds Small Amounts of Asbestos May Trigger Mesothelioma in People with Genetic Mutation, According to Surviving Mesothelioma 2Health News:Attorney from William Mattar Leads Discussion on Bicycle Accidents 2Health News:First Choice Emergency Room Announces Dr. Mariah N. Manzanares as Medical Director of Frisco, TX Facility 2Health News:First Choice Emergency Room Announces Dr. Mariah N. Manzanares as Medical Director of Frisco, TX Facility 3Health News:Celebrity Fashion Summer Party Dresses on sale at TheCelebrityDresses.com 2
... fall season can be just as bad as the ... over-the-counter (OTC) medicine; however, can quickly becoming an// overwhelming ... shelf of products that often times have very similar ... pharmacy of the Philadelphia College of Pharmacy at University ...
... the American Heart Association's 60th Annual Fall Conference of the ... high blood// pressure may be at risk of sleep breathing ... high blood pressure, 60 % of whom were affected by ... upper airway obstructions cause SDB. These obstructions can be complete ...
... new front in the war against flu, researchers at ... a novel compound that confers broad protection// against influenza ... work, reported online this week (Oct. 4, 2006) in ... peptide -- a small protein molecule -- that effectively ...
... that reviews of drugs, which are supported by the ... conclude// sympathetically as compared to independent reviews, reveals a ... that bias in drug trials is a common phenomenon ... which can have a more unbiased and systematic approach ...
... 20 Cuban deaf and blind children can hear now, ... has revolutionized the world of profound// neuro-sensorial auditory deficiency. ... International Health Centre in Havana, the Prensa Latina news ... speaking signs into electric signals, partially restoring the hearing ...
... premier hospital, the All India Institute of Medical Sciences (AIIMS), ... and garbage littered across the campus. ,In the last ... exposed serious flaws within India's best known public health facility ... 26 resident doctors, medical students and staff being admitted to ...
Cached Medicine News:Health News:Allergy OTC Medicines–Speak With Your Pharmacis 2Health News:Allergy OTC Medicines–Speak With Your Pharmacis 3Health News:Hypertensive Kids at risk of sleep disordered breathing 2Health News:Hypertensive Kids at risk of sleep disordered breathing 3Health News:New Drug Blocks Influenza, Including Bird Flu Virus 2Health News:New Drug Blocks Influenza, Including Bird Flu Virus 3Health News:AIIMS Campus - A Breeding Ground for Mosquitoes 2Health News:AIIMS Campus - A Breeding Ground for Mosquitoes 3
(Date:7/2/2015)... DUBLIN , June 26, 2015 ... of the "Vitamin D Market by Analog, Application, End-User ... report to their offering. This market is ... use of vitamin D in different applications and rising opportunities ... China , Italy , and ...
(Date:7/2/2015)... , July 2, 2015 Numotion,s Board of ... announced that Tamas Feitel has joined the ... Numotion after a highly successful 18 year career at ... driving strategy, profitability, and productivity to result in significant ... position was Chief Financial Officer for GE Healthcare Global ...
(Date:7/2/2015)... The report "Silage Inoculants & Enzymes Market ... Enterococcus), Enzymes (Fibre-digesting & Starch-digesting), Crop-type & Geography - ... Enzymes Market is expected to reach $489.05 Million by ... 2020. Browse 75 market Tables and ... P ages and an in-depth TOC on ...
Breaking Medicine Technology:Vitamin D Market by Analog, Application, End-User & by Region - Global Trends & Forecast to 2020: Increasing Recommendation By Doctors & Associations 2Vitamin D Market by Analog, Application, End-User & by Region - Global Trends & Forecast to 2020: Increasing Recommendation By Doctors & Associations 3Numotion Names Tamas Feitel Chief Financial Officer 2Silage Inoculants & Enzymes Market Worth $489.05 Million by 2020 2Silage Inoculants & Enzymes Market Worth $489.05 Million by 2020 3Silage Inoculants & Enzymes Market Worth $489.05 Million by 2020 4
... IRVINE, California , and AMSTERDAM , ... molecular cancer diagnostics, announced today that company,CEO Dr. Bernhard ... July 20 ,in Washington D.C. on the ... Food and Drug Administration (FDA) and,Center for Devices and Radiological ...
... , DETROIT , July 15 Caraco Pharmaceutical ... July 12, 2010 , NYSE Amex notified the Company that it ... standards that its audit committee be comprised of three independent members. ... of its non-compliance with Section 803(B)(2)(a) of NYSE Amex Company Guide ...
Cached Medicine Technology:Agendia to Provide Testimony at Public Meeting on FDA Oversight of Laboratory-Developed Tests 2Caraco Pharmaceutical Laboratories, Ltd. Receives Notice Regarding NYSE Amex Continued Listing Standards 2
... The Spectrum® Tissue Repair System is designed ... and shoulder soft tissue. It features ... roller system. Interchangeable suture hooks allow ... The Spectrum® Tissue Repair System is ...
... The Mini-Open Rotator Cuff Repair ... by,reducing procedure time, incision size and ... system,augments other rotator cuff repair systems ... of,three sizes of matched cortical gauge ...
Threaded cannula with cannulated obturator for use with Acufex Suture Punch; sterile packs, box of 10....
Threaded cannula for use with Suretac® II, sterile packs, box of 10....
Medicine Products: