Navigation Links
Perrigo's Partner Synthon Receives FDA Tentative Approval for Levocetirizine Solution - Generic Equivalent to Xyzal® Oral Solution
Date:5/18/2011

ALLEGAN, Mich., May 18, 2011 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO; TASE) and its partner Synthon Pharmaceuticals, Inc. today announced that it has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Levocetirizine Solution, 2.5 mg/5ml, a generic version of UCB's Xyzal® Oral Solution. Synthon believes it has a first to file ANDA application for the generic that can entitle it to 180 days of generic exclusivity. Synthon and UCB are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing.

Xyzal® Oral Solution is indicated for the treatment of indoor and outdoor allergies. It is estimated that it has annual sales of approximately $15 million dollars growing at 15% per year, according to data provided by Wolters, Kluwer.

Perrigo's Chairman and CEO Joseph C. Papa concluded, "This is another example of Perrigo's commitment to bring new products to market. Perrigo continues to deliver on its mission to provide quality, affordable healthcare to consumers."

Synthon's CEO Rudy Mareel, commented, "Levocetirizine is a prime example of several ANDAs for which Synthon has obtained 'First-Filer'-status with 180 days Hatch-Waxman marketing exclusivity. The tentative approval of Levocetirizine oral solution yet again is proof to Synthon's achievements and our fruitful cooperation with Perrigo."

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products and active pharmaceutical ingredients (API). The Company is the world's largest store brand manufacturer of OTC pharmaceutical products and infant formulas. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, th
'/>"/>

SOURCE Perrigo Company
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
2. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
3. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
4. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
5. HistoRx and Radiation Therapy Oncology Group Initiate Brain Tumor Biomarker Research Partnership
6. The Leukemia & Lymphoma Society and Cleveland Clinic Taussig Cancer Institute Announce Groundbreaking Partnership to Accelerate Drug Approvals
7. PDHI Launches ConXus Rewards, Announces Partnership With Hallmark Insights to Support Incentive-Driven Wellness Programs
8. JDRF and Lilly Partner to Fund Research to Identify Beta Cell Biomarkers
9. Rigel Announces Initiation of Phase 1 Clinical Trial of R343 for Allergic Asthma by its Partner Pfizer
10. UNICEF Partners With Causes on Facebook to Launch Charity Gift Feature
11. HealthMedias Strongest Single Quarter Results: Growth Driven by Product Enhancements, New Partnerships
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... May 21, 2013  Decision Resources, one ... firms for pharmaceutical and healthcare issues, finds ... on key efficacy endpoints, including overall survival ... most influence over surveyed U.S. and European ... positive, HER2-negative breast cancer. The two novel ...
(Date:5/21/2013)... Calif. , May 21, 2013 /PRNewswire/ ... embedded-ultrasound platform, today announced the introduction of ... allows complete network-based communications with all cQuest ... latest embedded-ultrasound technology, including this new capability, ... Sao Paulo, Brazil from May ...
(Date:5/21/2013)...  The North Shore-LIJ Health System is expanding a ... at North Shore University Hospital in Manhasset, ... at Forest Hills (NY) Hospital. ... new pilot program strengthens patient safety by providing hospitals ... first time in the US that remote video auditing ...
Breaking Medicine Technology:Thought-Leader Opinion and Clinical Data Indicate that Emerging Agents from Two Drug Classes Have Efficacy Advantages Over Currently Used Therapies for HR-Positive, HER2-Negative Breast Cancer 2Cephasonics Unveils Next-Generation Wireless-Imaging Technology for cQuest Ultrasound Hardware Platforms 2North Shore-LIJ Extends Use of 3rd Party Remote Video Auditing into ORs 2North Shore-LIJ Extends Use of 3rd Party Remote Video Auditing into ORs 3North Shore-LIJ Extends Use of 3rd Party Remote Video Auditing into ORs 4
(Date:5/21/2013)... NY (PRWEB) May 21, 2013 ... connects people with trusted services & businesses, announced today ... business Emergency Medical Care. , Emergency Medical Care is ... care services 24 hours a day. The guarantee ... appointment is a promising resource for the neighborhood and ...
(Date:5/21/2013)... Reporter , , MONDAY, May 20 (HealthDay News) -- Young ... a higher risk of getting into car crashes, but ... missed sleep on weekends puts them in even greater ... is another challenge to adolescents that comes with lack ... founder of the Center for Injury Research and Prevention ...
(Date:5/21/2013)... May 21 (HealthDay News) -- Racial disparities exist in ... in the United States, according to a large new ... surgery as part of their initial treatment, researchers found ... to have surgery in the early stages of the ... stage 1 and stage 2 disease than white patients. ...
(Date:5/21/2013)... of physical activity appears to be an independent ... obstructive pulmonary disease (COPD) will end up being ... researchers in Connecticut. The study also corroborates an ... with an increased incidence of hospitalizations among patients ... will be presented at the ATS 2013 International ...
(Date:5/21/2013)... CA (PRWEB) May 21, 2013 After the ... fitness boot camp business Fit Body Boot Camp Goderich ... starting June 3rd at its Goderich fitness center ... Boot Camp’s 1,000 lb. Meltdown Challenge’s goal is to inspire ... 1,000 pounds in 28 days. The fee to participate ...
Breaking Medicine News(10 mins):Health News:Romio Announces Mini Video Series Featuring Local Business Emergency Medical Care 2Health News:Weekend 'Catch-Up' Sleep May Cut Young Drivers' Crash Risk 2Health News:Racial Disparities Seen in U.S. Lung Cancer Treatment 2Health News:Exercise levels may predict hospitalizations in COPD population 2Health News:Goderich Fitness Center Promotes 2nd Annual 1,000 lb. Meltdown Challenge to Fight Obesity With All Proceeds Raised Going to Local Charity 2Health News:Goderich Fitness Center Promotes 2nd Annual 1,000 lb. Meltdown Challenge to Fight Obesity With All Proceeds Raised Going to Local Charity 3
... ... in Christ for A Day of Breast Health Awareness, Education and Screenings , ... Philadelphia, Pa. (Vocus) October 2, 2009 -- ... with Praise is The Cure and the Health Ministry Program will have a day-long celebration ...
... ... with chronic sinusitis and recurring sinus infections. When antibiotics fail they are left with little ... ... SinusWars LLC has been treating sinus related conditions for years and has noticed an increase ...
... "Profile America" feature from the U.S. Census Bureau: , (Logo: ... 2: FIRST GYM INSTRUCTORS , Profile America ... staying fit. Often, they have exercise equipment at home, ... But most people interested in fitness plan their busy ...
... has discovered a new way to classify stomach cancers, ... toward designing more effective treatments and improving long-term survival. ... and represents the second leading cause of cancer deaths ... from patients in Singapore, Australia and the United Kingdom ...
... 1 Two interactive computer tools released today by ... emergency planners and responders select and run alternate care ... a surge in seriously ill patients requiring acute care ... alternate care sites. , Alternate care facilities ...
... ... of hydrolysates, the performance of FBS and the consistency of a defined media. , ... Fort Collins, CO (PRWEB) October 4, ... hamster ovaries) cell line enhancement called Zap-CHO . Zap-CHO is designed to deliver superior ...
Cached Medicine News:Health News:More than 500 Breast Cancer Survivors and Community Supporters to Attend Annual 'Praise is The Cure' Event 2Health News:SinusWars LLC Launches a Successful and All Natural Alternative to Antibiotics in the Fight to Treat Chronic Sinusitis 2Health News:Duke/Singapore scientists find new way to classify gastric cancers 2Health News:New Tools Help Emergency Planners Select Alternate Care Facilities and Transfer Patients During Disasters 2Health News:InVitria Launches Zap-CHO to Enhance CHO Cell Culture Performance 2Health News:InVitria Launches Zap-CHO to Enhance CHO Cell Culture Performance 3
... available in four standard sizes. They offer ... to expensive, reusable brain biopsy needles. In ... Guide offers a simple yet secure method ... of our biopsy needles, using frameless stereotactic, ...
A complete system of cannulas, needles and rasps specifically designed for inside-out meniscal repair procedures....
... Flexible Digital Implant offers surgeons an alternative ... correction of a hammertoe deformity. The prosthesis ... and is designed for the proximal interphalangeal ... Futura FDI features an anatomic hinge design ...
... Therapy has been approved for use as ... of seizures in adults and adolescents over ... seizures that are refractory to antiepileptic medications. ... 5 controlled, clinical trials. Efficacy, measured as ...
Medicine Products: