Navigation Links
Schering-Plough/MERCK Pharmaceuticals Receives Not-Approvable Letter from FDA for Loratadine/Montelukast
Date:4/25/2008

KENILWORTH and WHITEHOUSE STATION, N.J., April 25 /PRNewswire/ -- Schering-Plough/MERCK Pharmaceuticals (SPM) today confirmed that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for a proposed fixed combination of loratadine and montelukast for the treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion.

The New Drug Application filing for loratadine/montelukast was accepted by the FDA for standard review on August 26, 2007. The medicine is a single tablet that contains the active ingredients of CLARITIN (R) (loratadine) and SINGULAIR(R) (1) (montelukast sodium), both of which are indicated for the relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

Schering-Plough/MERCK Pharmaceuticals is evaluating the agency's response.

The FDA decision does not impact the availability or continued use of CLARITIN or SINGULAIR.

About CLARITIN

Schering-Plough received U.S. Food and Drug Administration (FDA) approval on November 27, 2002, for the over-the-counter (OTC) sale of the original prescription strength of CLARITIN Tablets.

About SINGULAIR

SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children two years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children six months and older. In clinical studies for both SAR and PAR, SINGULAIR was generally well tolerated with a safety profile similar to that of placebo. Adverse events varied by age. The most commonly reported adverse events, occurring at a frequency of >1% and at an incidence greater than placebo, regardless of causality assessment, were sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, headache, otitis media, pharyngitis and increased ALT. SINGULAIR is contraindicated in patients with hypersensitivity to any of its components.

About S
'/>"/>

SOURCE Schering-Plough Corporation; Merck & Co., Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Keryx Biopharmaceuticals Receives Nasdaq Notification
2. Amylin Pharmaceuticals to Present at Morgan Stanley Global Healthcare Unplugged Conference
3. Idenix Pharmaceuticals to Present at the Morgan Stanley Global Healthcare Unplugged Conference
4. Aida Pharmaceuticals, Inc. Announces Completion of Research Institute Acquisition
5. Anadys Pharmaceuticals to Report First Quarter 2008 Financial Results
6. New Fragment-based Drug Discovery Platform Announced Between IOTA Pharmaceuticals Ltd, Cambridge (UK), and Beactica AB, Uppsala (Sweden)
7. MacroChem Acquires Virium Pharmaceuticals
8. GlaxoSmithKline to Acquire Sirtris Pharmaceuticals, a World Leader in Sirtuin Research and Development
9. Rib-X Pharmaceuticals to Present at Cambridge Healthtech Institutes 2nd Annual Challenge of Antibacterial Development Conference
10. NexGenix Pharmaceuticals Presents Data on a Novel Small Molecule Inhibitor of Heat Shock Protein 90 (Hsp90) at the Annual Meeting of the American Association for Cancer Research (AACR); Scientific Advisory Board Chairman Tyler Jacks Named President-elect
11. Paratek Pharmaceuticals Completes $40 Million Private Placement to Finance Clinical Programs Including Oral Antibiotic to Combat MRSA and Other Infections
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... , July 24, 2014  Neogen Corporation (Nasdaq: ... future forecasts of its potential revenue from new rodenticide ... to investors and analysts on July 22, 2014, Neogen,s ... analysts regarding this research. "It was my ... about the potential of a new type of rodenticide, ...
(Date:7/24/2014)... (PRWEB) July 24, 2014 The first ... Dose Escalation in First in Human Studies” will cover ... better go/no-go decisions. , With increasing R&D costs and ... companies need to maximize the knowledge collected in early ... and improve success in late stage development. , Next, ...
(Date:7/24/2014)... 2014   Cypher Genomics, Inc., the ... Adam Simpson as president and chief ... comprehensive annotation and interpretation of individual human genomes ... "Cypher,s technology has the potential to play a ... accuracy, optimizing therapeutic approaches and reducing adverse drug ...
(Date:7/23/2014)... YORK , July 24, 2014 ... Immune Pharmaceuticals Inc. (OTCQX and NASDAQ OMX First ... "Immune" or "the Company"), announced a collaboration to ... pemphigoid last night at an event attended by ... interested parties. Lyfebulb is a health and wellness ...
Breaking Biology Technology:Neogen comments on SenesTech 2Best Practices for Optimizing Dose Escalation in First in Human Studies, New Webinar August 6th Hosted by Xtalks 2Cypher Genomics Announces the Appointment of Adam Simpson as President and COO to Advance Transformative Genome Interpretation Technology 2Cypher Genomics Announces the Appointment of Adam Simpson as President and COO to Advance Transformative Genome Interpretation Technology 3Innovative Collaboration To Increase Awareness Of Bullous Pemphigoid, A Rare Autoimmune Disease Of The Skin 2Innovative Collaboration To Increase Awareness Of Bullous Pemphigoid, A Rare Autoimmune Disease Of The Skin 3Innovative Collaboration To Increase Awareness Of Bullous Pemphigoid, A Rare Autoimmune Disease Of The Skin 4Innovative Collaboration To Increase Awareness Of Bullous Pemphigoid, A Rare Autoimmune Disease Of The Skin 5
... - If you're a casual follower of the news about ... that virtually every researcher wearing a white coat is somehow ... ,Not so. While Wisconsin is a national leader in stem ... Wisconsin-Madison beginning in the mid-1990s, that type of biomedical ...
... today proposed a joint public-private initiative to allocate ... renewable energy programs in Wisconsin. , ,Doyle said the ... grants that would come from business development fund allotments ... an additional $370 million in private investment to marshal ...
... the casual observer, responders contained the recent E. coli ... health professionals, the automated system used to identify the ... improvement. , ,Still, information technology played a key role ... and it will play an even greater role in ...
Cached Biology Technology:Biomedical Alliance about more than stem cells 2Biomedical Alliance about more than stem cells 3Doyle announces $80M renewable energy strategy 2Doyle announces $80M renewable energy strategy 3Doyle announces $80M renewable energy strategy 4Technology played key role in E. coli alerts 2Technology played key role in E. coli alerts 3Technology played key role in E. coli alerts 4
(Date:7/23/2014)... of identical twins has found that early reading skill ... the journal Child Development , was conducted by ... London. , "Since reading is an ability that can ... according to Stuart J. Ritchie, research fellow in psychology ... "Early remediation of reading problems might aid not only ...
(Date:7/23/2014)... Carolina State University shows that urban "heat islands" are ... One factor is that researchers have found warmer temperatures ... scale insect a significant tree pest by ... more adult gloomy scales on urban trees. , "We,d ... gloomy scale in cities, and now we know why," ...
(Date:7/23/2014)... cultured from cystic fibrosis patients, scientists at the UNC ... have shown that a new CF drug counteracts the ... The finding, published today in the journal Science ... becomes unstable and loses its ability to function properly ... research offers several insights into how novel CF pharmacotherapies ...
Breaking Biology News(10 mins):Stronger early reading skills predict higher intelligence later 2Urban heat boosts some pest populations 200-fold, killing red maples 2Urban heat boosts some pest populations 200-fold, killing red maples 3UNC researchers find unsuspected characteristics of new CF drugs, offering potential paths to more effective therapies 2UNC researchers find unsuspected characteristics of new CF drugs, offering potential paths to more effective therapies 3UNC researchers find unsuspected characteristics of new CF drugs, offering potential paths to more effective therapies 4
... The National High Magnetic Field Laboratory at Florida ... system that will transform the study of complex environmental ... biological fuels, for example, could lead to applications for ... fuels. The 21-tesla superconducting magnet, combined with a ...
... responsible for about two-thirds of toxic lead that African-American ... two-thirds of the 20th century, according to a new ... Researchers from Case Western Reserve University say what ... across the U.S. and reinforces concerns about the health ...
... a national attention throughout China in the wake of the ... for milk quality control, particularly protein concentration, are easy to ... to monitor the raw milk content in formula milk and ... Cell Research , could lead to a completely new standard ...
Cached Biology News:Major magnet grant to advance state-of-the-art in chemical analysis 2Major magnet grant to advance state-of-the-art in chemical analysis 3Leaded gasoline predominant source of lead exposure in latter 20th century 2Leaded gasoline predominant source of lead exposure in latter 20th century 3New biomarker for raw milk quality detection 2
... is used to screen blots of mini format ... screen up to 40 different antibodies or sera ... The apparatus includes a base plate, 2 separate, ... 8 x 7 cm membranes, and gaskets and ...
Fingerprinting II database sharing tools is an optional module for the Fingerprinting II Basic software package that enables peer-to-peer data exchange over the internet and provides external databas...
... Fingerprinting II ... is an optional ... principal component analysis, ... analysis and MANOVA, ...
Fingerprinting II comparative quantification and polymorphism analysis is an optional module that adds comparative quantification and polymorphism analysis functions to the Fingerprinting II Basic so...
Biology Products: