Navigation Links
Tris Announces NDA Acceptance of Extended Release Carbinoxamine Oral Suspension for the Treatment of Allergies in Kids Two Years and Older
Date:3/9/2011

MONMOUTH JUNCTION, N.J., March 9, 2011 /PRNewswire/ -- Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced today that the US Food and Drug Administration (FDA) has accepted its Extended Release Carbinoxamine Oral Suspension NDA for the treatment of allergies in kids two years and older.  If approved, Tris Pharma's Extended Release Suspension will provide an alternative to the currently available immediate release formulations.

Carbinoxamine is a mildly sedating antihistamine with years of proven safety and efficacy.  Prior to 2006 carbinoxamine was widely used, with more than 100 marketed Carbinoxamine containing products including extended release solid dose and combination products.  However, nearly all of these were older products which hadn't gone through the FDA's rigorous approval process.  Following the 2006 DESI review, the FDA removed all carbinoxamine based products with the exception of two immediate release formulations which had been reviewed, creating a void for patients and doctors who valued the benefits associated with an extended release formulation.

A leading New York based pediatrician, Dr. Laura Garabedian, who often prescribes Carbinoxamine said, "I've always found Carbinoxamine extremely effective in treating allergy symptoms in children but don't typically prescribe it as first line therapy because the existing immediate release formulations need to be dosed multiple times per day including a dose while the child is in school thus making compliance poor.   I am looking forward to a true 12 hour formulation that tastes good.   The new product profile should translate to improved compliance and better outcomes."

Ketan Mehta, Tris President and CEO added, "This is the fourth NDA submission based on Tris' OralXR+ technology platform including Nexiclon™ XR,  a recently launched first ever 24-hour liquid Extended Rel
'/>"/>

SOURCE Tris Pharma
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. ViroPharma Announces Securities Repurchase Program
2. Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2010 Financial Results
3. Warner Chilcott Announces Secondary Equity Offering
4. K-V Pharmaceutical Company Announces Comprehensive Patient Assistance Program for Makena™
5. PDL BioPharma Announces Conversion Rate Adjustments for 2.00% Convertible Senior Notes Due February 15, 2012 and 2.875% Convertible Senior Notes Due February 15, 2015
6. Vermillion Announces Presentation of Positive Ovarian Biomarker Data for Next Generation Test
7. Genus Oncology, LLC Announces Orphan Drug Status for GO-203-2c for Treatment of Pancreatic Cancer
8. Amicus Therapeutics Announces FDA Agreement to Commence Phase 2 Study of AT2220 Co-administered with Enzyme Replacement Therapy for Pompe Disease
9. Hill-Rom Announces Second Quarter 2011 Dividend
10. Idenix Announces Data Presentations at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL)
11. Jazz Pharmaceuticals Announces Fourth Quarter and Full Year 2010 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... 2015 More than 1,500 substance abuse prevention ... in Indianapolis Aug. 2-6 for ... Training Institute . The week-long training, held at the ... of our nation,s biggest public health challenges – youth ... is a one-of-a-kind intensive training opportunity, offering more than ...
(Date:7/31/2015)... , July 31, 2015  Boston Children,s ... benefiting from 3D printing of their anatomy before ... life-threatening cerebrovascular malformations (abnormalities in the brain,s blood ... Reporting online today in the Journal of ... of 3D printing and synthetic resins to create ...
(Date:7/31/2015)... 2015 Egalet Corporation (Nasdaq: EGLT ... focused on developing, manufacturing and marketing innovative pain ... announced underwritten public offering of 7,666,667 shares of ... of $11.25 per share. The shares of common ... upon the exercise in full by the underwriters ...
Breaking Medicine Technology:Community Leaders From Across The Country Head To Indianapolis For CADCA 2015 Mid-Year Training Institute Aug. 2-6 23D Printing Helps Doctors Rehearse Complex Brain Procedures 23D Printing Helps Doctors Rehearse Complex Brain Procedures 33D Printing Helps Doctors Rehearse Complex Brain Procedures 4Egalet Announces Closing of Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares 2Egalet Announces Closing of Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares 3Egalet Announces Closing of Public Offering of Common Stock and Exercise in Full of Underwriters' Option to Purchase Additional Shares 4
(Date:8/1/2015)... ... August 01, 2015 , ... On March 19, 2015 Phil Valentine – the Executive Director ... Appalachian Trail by stepping off Springer Mountain and heading north. Since that day, ... Phil reached Connecticut and was greeted by friends and family. He visited CCAR and ...
(Date:7/31/2015)... ... July 31, 2015 , ... When the weather turned hot and ... new type of sod called Leisure Time(TM) zoysia . It's nicknamed LTZ(TM) for ... commemorate introduction of this new type of sod, Super-Sod is giving away red Adirondack ...
(Date:7/31/2015)... (PRWEB) , ... July 31, 2015 , ... Ticket Down ... is currently going on in Chicago at Grant Park. The festival will end ... of North America to Chicago for the annual Lollapalooza. This unique and unbelievably ...
(Date:7/31/2015)... ... July 31, 2015 , ... ... run by GoodThreads. The store can be accessed by visiting http://www.curemeso.org/store . ... which are customizable. The best part: whenever a product is purchased, the Meso ...
(Date:7/31/2015)... , ... July 31, 2015 , ... There’s no better ... even when it comes time to cook the next meal, making July the most ... by practicing best grilling tips and recipes. , Make the next cookout different than ...
Breaking Medicine News(10 mins):Health News:Connecticut Executive Hikes Appalachian Trail to Raise Awareness About Recovery. 2Health News:Super-Sod Introduces Leisure Time(TM) Zoysia Grass with an Adirondack Chair Promotion 2Health News:Cheap 2015 Lollapalooza Tickets: Ticket Down Slashes Ticket Prices on Lollapalooza Tickets at Grant Park in Chicago for Saturday, August 1st and Sunday, August 2nd 2Health News:Mesothelioma Organization Launches New Store 2Health News:Mesothelioma Organization Launches New Store 3Health News:King Kullen Honors National Hot Dog and Blueberry Month 2Health News:King Kullen Honors National Hot Dog and Blueberry Month 3
... parents’ when compared to rugby-codes. But this opinion stands challenged, ... for the highest injuries as compared to all other types ... topped the charts of contact sports injuries, the second place ... and the last , being soccer. ,A report published ...
... suspected to have contacted meningococcal disease are being treated at ... who hail from Cobar and Mudgee respectively, are showing signs ... possible to relate both the cases, based on the evidence ... Western Area Health Service. In addition, family members and friends ...
... SOS has found that firms are concentrating on "tracking ... than stockpiling protective equipment like gloves and masks in ... // ,The survey found that only 36 of ... steps, "Organizations with distributed, global workforces want to be ...
... expression pattern of certain microRNA’s heve been found that ... ,The analysis of these findings indicates that miRNAs may ... for lung cancer. ,The Ohio State University ... of Medicine, Tokyo, Japan; National Cancer Centre Research Institute, ...
... LONDON - A drug trial in northwest London went horribly ... trial are now battling for life at the emergency ward ... in the trial of a drug to treat conditions such ... volunteers were given a placebo and were healthy, but the ...
... frozen embryos are stored in Britain. They are living balls of ... their lives to begin again. // , Lois Walker ... was born in April 2000. Her gestation period lasted for more ... been an eight-celled embryo and spent about 30 months in a ...
Cached Medicine News:Health News:Lung cancer molecular profile discovered by researchers. 2Health News:Frozen embryos stored in Britain 2
The ImagingPlanet 55 mm Surgical Microscope Adapter. Superior optical quality and precise engineering make this 55mm focal length adapter an excellent decision for use with your Zeiss surgical micro...
... Capture Archive Manage ... Images. ,Introducing Optronics DVMR- office, ... system designed for the physician's ... from a variety of high-resolution ...
... Optronics QuantiFIRE represents the latest innovation ... scientific grade CCD imaging for microscopy. ... Monochrome CCD camera developed exclusively for ... fluoresence or NIR imaging applications where ...
... This system is the most ... world. Developed in the USA after ... safety, and complete precision with maximum ... exfoliation. It is superior to traditional ...
Medicine Products: