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:12/22/2014)... /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSX.V: ... the development of autologous cell therapies, announced today the ... Calgary in conjunction with co-authors from Kyoto University and ... company,s ongoing clinical research using dermal sheath cup (DSC) ... The paper entitled " Hair Follicle Dermal Stem ...
(Date:12/22/2014)... December 22, 2014 The ... publication of original research, reviews and editorials addressing ... clinical practice, today published a provocative article exploring ... development, progression and potential treatment of prostate cancer. ... research and proposes the possibility that there could ...
(Date:12/19/2014)... Charm Sciences is pleased to announce ... of Aflatoxin M1 in raw commingled milk is the ... validation. The peer reviewed report of the validation by ... Agricultural and Fisheries Research (ILVO-T&V) has been published by ... the most toxic aflatoxin and a known carcinogen, can ...
(Date:12/19/2014)... 19, 2014 Bina Technologies, Inc. (Bina, ... they have been acquired by Roche (SIX: RO, ROG; ... held company that provides a big data platform for ... data for the academic and translational research markets.  Bina ... will continue to focus on development of their innovative ...
Breaking Biology Technology:Newly Released Peer-Reviewed Publication Further Validates RepliCel's Use of Dermal Sheath Cup Cells to Treat Pattern Baldness 2Newly Released Peer-Reviewed Publication Further Validates RepliCel's Use of Dermal Sheath Cup Cells to Treat Pattern Baldness 3Newly Released Peer-Reviewed Publication Further Validates RepliCel's Use of Dermal Sheath Cup Cells to Treat Pattern Baldness 4Newly Released Peer-Reviewed Publication Further Validates RepliCel's Use of Dermal Sheath Cup Cells to Treat Pattern Baldness 5Prostate Cancer Experts Dissect the Role of Follicle-stimulating Hormone in the Development, Progression and Potential Treatment of Prostate Cancer 2Prostate Cancer Experts Dissect the Role of Follicle-stimulating Hormone in the Development, Progression and Potential Treatment of Prostate Cancer 3Prostate Cancer Experts Dissect the Role of Follicle-stimulating Hormone in the Development, Progression and Potential Treatment of Prostate Cancer 4Charm Sciences Achieves Independent Validation of First 15 Minute Quantitative Screening Method for Aflatoxin M1 2Bina Technologies is acquired by Roche. 2Bina Technologies is acquired by Roche. 3
... to Host Conference Call at 12:30 p.m. Eastern Time, September 19, ... ... Sept. 19 Indevus,Pharmaceuticals, Inc. (Nasdaq: IDEV ) today announced that ... obtained the,United States rights to SANCTURA(R) and SANCTURA(R) XR. In connection with,Allergan,s ...
... Corporation,(Nasdaq: CRGN ), a clinical-stage biopharmaceutical company ... M.D., has been appointed,President and Chief Executive Officer, ... remain with the Company through the end,of 2007, ... on CuraGen,s,Board of Directors until the Annual Stockholders ...
... for ... inflammatory bowel disease., OKLAHOMA CITY, Sept. 18 Altheus Therapeutics, ... trials,testing the efficacy of its therapy for the treatment of inflammatory ... by the,Oklahoma Seed Capital Fund and Oklahoma Equity Partners. About ...
Cached Biology Technology:Indevus Announces Allergan as New Partner for SANCTURA Brand 2Indevus Announces Allergan as New Partner for SANCTURA Brand 3Indevus Announces Allergan as New Partner for SANCTURA Brand 4Indevus Announces Allergan as New Partner for SANCTURA Brand 5Indevus Announces Allergan as New Partner for SANCTURA Brand 6CuraGen Corporation Announces Appointment of Dr. Timothy M. Shannon as President and Chief Executive Officer 2CuraGen Corporation Announces Appointment of Dr. Timothy M. Shannon as President and Chief Executive Officer 3CuraGen Corporation Announces Appointment of Dr. Timothy M. Shannon as President and Chief Executive Officer 4CuraGen Corporation Announces Appointment of Dr. Timothy M. Shannon as President and Chief Executive Officer 5Altheus Therapeutics Secures $3.6 Million in Venture Capital 2
(Date:12/10/2014)... , Dec. 08, 2014 Research and Markets ... addition of the "Biometrics Market in Japan ... http://photos.prnewswire.com/prnh/20130307/600769 The ... such as rural banking and upgradation of the ... witnessed in the market. Besides the aforementioned projects, ...
(Date:12/5/2014)... , Dec. 4, 2014  Tute Genomics, a leader ... million in Series A1 funding led by UK-based Eurovestech. ... participated in the investment round. "We are ... community adopts next-generation sequencing and seeks new approaches for ... Reid Robison , MD MBA, and CEO of Tute ...
(Date:12/3/2014)... 2, 2014 As part of our commitment ... is pleased to announce the release of a new ... collect the workforce data that they need. ... left by existing readers. Many such devices have serious ... modern technology. Older models force users to navigate numerous ...
Breaking Biology News(10 mins):Biometrics Market in Japan 2014-2018: Key Vendors are DDS, Fujitsu, Hitachi and NEC 2Tute Genomics Raises $2.3 Million to Scale Up Cloud-Based Genome Analytics and Accelerate Personalized Medicine 2Tute Genomics Raises $2.3 Million to Scale Up Cloud-Based Genome Analytics and Accelerate Personalized Medicine 3Inception Technologies to Release New Biometric Reader 2
... A major step in commercializing the groundbreaking research ... University of Minnesota signed an exclusive, global license agreement ... worldwide attention in 2008 when her team announced that ... laboratory. The technology licensed to Miromatrix holds the ...
... Calif., Feb. 16, 2010 Butterfly experts have suspected for ... in explaining wing color diversity. Now, for the first time, ... at least in nine Heliconius species. ... ultraviolet colors also have UV-yellow pigment on their wings, reports ...
... coastal fog has decreased significantly over the past 100 years, ... according to a new study by University of California, Berkeley, ... a natural cycle of the result of human activity, but ... entire redwood ecosystem, the scientists say. , "Since 1901, the ...
Cached Biology News:U of Minnesota finalizes license agreement to form start-up company based on Doris Taylor research 2Butterfly vision, wing colors linked, UCI study finds 2Fog has declined in past century along California's redwood coast 2Fog has declined in past century along California's redwood coast 3Fog has declined in past century along California's redwood coast 4