Navigation Links
Caraco Pharmaceutical Laboratories Ltd. Announces Tentative FDA Approval for Generic Zyrtec Chewable(R)
Date:10/5/2007

DETROIT, Oct. 5 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Chewable Tablets, 5 mg and 10 mg (Cetirizine HCl Chewable). Final approval to market this product is anticipated subsequent to the expiry of patent protection on December 25, 2007.

Cetirizine HCl Chewable is indicated for the relief of symptoms associated with seasonal allergic rhinitis due to allergens in adults and children 2 years of age and older; perennial allergic rhinitis in adults and children 6 months of age and older; and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. This tentative approval is the bioequivalent to Zyrtec Chewable(R), a registered trademark of Pfizer, Inc. Zyrtec Chewable(R) tablets had U.S. sales of approximately $75 million for the 12-month period ended June 30, 2007, according to IMS Data.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this tentative approval and look forward to the expiration date of the patent on December 25, 2007, which will allow Caraco to market the product. We feel that Cetirizine HCl Chewable complements our previously announced FDA tentative approval of Cetirizine Hydrochloride Immediate Release Tablets, 5 mg and 10 mg, and both products will be positive additions to our portfolio by expanding our product offerings."

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and priva
'/>"/>

SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. South Africa Wins landmark case against pharmaceutical giants
2. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
3. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
4. Setting up a new pharmaceutical industry in India
5. Medicis Pharmaceutical company enters pediatric market
6. Supply of Radiopharmaceuticals Hampered by Attacks
7. Pharmaceutical companies are targeting patients
8. FDA approves Watson Pharmaceuticals Oxytrol patch
9. Ranbaxy Pharmaceuticals Inc awarded the prestigious outstanding supplier award received from Wal-Mart
10. Indian Pharmaceutical Industries Stops Manufacturing And Sale Of Valdecoxib
11. Pharmaceutical industries grant for R&D to be monitored
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/23/2014)... August 23, 2014 The MPWMD Board of ... of AWGs as a sole source of water for commercial ... of local architect, Ron Brown of Archworks, LLC in Carmel, ... is the first time a water district in the State ... alternative water source. AWGs at this time can now ...
(Date:8/23/2014)... TX (PRWEB) August 23, 2014 Youth ... of Texas. It’s no different in Houston, TX. Substance ... are falling victim to drug and alcohol dependency in ... are looking to beat substance abuse, but don’t know ... juvenile treatment facility can be a challenge because most ...
(Date:8/22/2014)... 23, 2014 The IT manager of ... hosting for several years. He has recently announced that ... hosting suppliers in 2014. , GoDaddy is a popular ... features and great hosting solutions at affordable rates. It ... for shared hosting plans depend on the length of ...
(Date:8/22/2014)... Las Vegas, NV (PRWEB) August 22, 2014 ... affordable email marketing services that currently helps more ... marketing efforts has caught the attention of Shane Michaels, ... a still a crucial element for any online marketing ... media replacing email in the marketing world,” reports Michaels. ...
(Date:8/22/2014)... Buying a policy for different life insurance products can ... coverage types by insurers in the U.S. The Quotes Pros ... the public using its sortable tool at http://quotespros.com/life-insurance.html . ... is expected to promote the discounts and special offerings for ... The system is designed to help an adult locate a ...
Breaking Medicine News(10 mins):Health News:Historical Moment in the Monterey Peninsula, Brings Drought Relief Solution to California, with the Help of EcoloBlue and AWG Technology 2Health News:New Houston Hotline Assisting Juveniles in Locating Dependable Rehabilitation Help 2Health News:AWeber: Review Exposes Affordable Provider of Opt-In Email Marketing Services 2Health News:Principal Life Insurance Policies Now Quoted for Adults at Insurance Website Online 2
... and Associates Inc.,announced today the release of the second ... a follow up to the national best selling,handbook designed ... Care is being published with the Instructor,s Manual, which,offers ... 77 million baby boomers approach retirement age, it is,anticipated ...
... doors to area ... youths on September 28, PORTLAND, Ore., Sept. 25 More than ... learn and grow with,the grand opening of the Regence Boys & Girls Club. ... Regence,the largest in the company,s history. The facility is Portland,s first,completely new Club ...
... Special Packaging, PARSIPPANY, N.J., Sept. 25 PNY ... flash media, USB drives,graphic cards and other peripherals, announced ... the Cure to support the fight against breast,cancer. Komen ... of,breast cancer survivors and activists committed to ending breast ...
... John Edwards announced yesterday a new proposal for ... US and,abroad. His plan also includes greater action ... health services., "We in New Hampshire welcome ... on funding," said Reverend Paige Blair, Rector at,St. ...
... George Mason University professor of psychology, Raja ... the National Institutes of Health to conduct research ... His program, "Apolipoprotein, Attention and Alzheimer,s disease," will ... adults for four years using cognitive, genetic and ...
... body, HOUSTON, Sept. 25 Can you tell ... visit The John P. McGovern Museum of Health and,Medical ... the latest,exhibit -- Sesame Street Presents: The Body -- ... 4, 2007 and January 13, 2008.,The exhibit offers an ...
Cached Medicine News:Health News:Home Health Aide: Guidelines for Care Second Edition Released 2Health News:Home Health Aide: Guidelines for Care Second Edition Released 3Health News:Home Health Aide: Guidelines for Care Second Edition Released 4Health News:Grand Opening of Regence Boys & Girls Club Marks a Milestone in Historic New Columbia Community Revitalization 2Health News:Grand Opening of Regence Boys & Girls Club Marks a Milestone in Historic New Columbia Community Revitalization 3Health News:PNY Technologies and Susan G. Komen for the Cure Partner to Raise Awareness of Breast Cancer 2Health News:Exciting New Plan from John Edwards on AIDS; Plan is 'Bold and Achievable,' say New Hampshire Activists 2Health News:George Mason University professor receives $2.6 million NIH grant to study Alzheimer's disease 2Health News:Sesame Street Exhibition Makes Texas Premier at The Health Museum 2Health News:Sesame Street Exhibition Makes Texas Premier at The Health Museum 3Health News:Sesame Street Exhibition Makes Texas Premier at The Health Museum 4Health News:Sesame Street Exhibition Makes Texas Premier at The Health Museum 5Health News:Sesame Street Exhibition Makes Texas Premier at The Health Museum 6
(Date:8/22/2014)... Research and Markets has announced the addition ... Report 2014" report to their offering. ... 2014 is a professional and in-depth study on the ... a focus on the Chinese situation. The report ... classifications, applications and industry chain structure. The particulate respirators ...
(Date:8/22/2014)... , Aug. 22, 2014  Cannabis Science, Inc. ... formulation-based drug development and related consulting, is pleased ... international medical cannabis conference taking place at the ... , on October 22, 2014.  The multilingual ... such as researchers, health professionals, and patients, to ...
(Date:8/21/2014)... Conn. , Aug. 21, 2014  Aptuit ... West Lafayette, Indiana , has enhanced ... and characterization of small and large molecules, including ... of the Bruker maXisPlus Q-TOF mass spectrometer. ... Goldman , CEO, Aptuit, said, "The expanded large ...
Breaking Medicine Technology:Global and Chinese Particulate Respirators Industry Report 2014 2Cannabis Science, Inc. (CBIS) to Sponsor 3rd International Conference on Cannabinoids in Medicine in October 2014 in Strasbourg, France 2Cannabis Science, Inc. (CBIS) to Sponsor 3rd International Conference on Cannabinoids in Medicine in October 2014 in Strasbourg, France 3Aptuit SSCI Adds Ultra High Resolution Q-TOF Mass Spectrometer for Large & Small Molecule Analyses 2
... (NASDAQ: MASI ) today announced that in line ... Cost of Care by Taking Noninvasive Monitoring to New Sites ... (SpHb®) will further the company,s stated mission,  Masimo is introducing ... ransfusion R elated C ost R eduction ...
... JAZZ ) today announced that the company will host ... 2011 at 4:30 p.m. EST/9:30 p.m. GMT. During the call, ... quarter and full year 2011 financial results. The ... Investors section of the Jazz Pharmaceuticals, website at www.jazzpharmaceuticals.com ...
Cached Medicine Technology:Masimo Announces "Better Care" Program - A Hospital Risk-Share Program for Blood Transfusion Related Cost Reduction with SpHb®, and $30 SpHb Sensor Price 2Masimo Announces "Better Care" Program - A Hospital Risk-Share Program for Blood Transfusion Related Cost Reduction with SpHb®, and $30 SpHb Sensor Price 3Masimo Announces "Better Care" Program - A Hospital Risk-Share Program for Blood Transfusion Related Cost Reduction with SpHb®, and $30 SpHb Sensor Price 4Masimo Announces "Better Care" Program - A Hospital Risk-Share Program for Blood Transfusion Related Cost Reduction with SpHb®, and $30 SpHb Sensor Price 5Masimo Announces "Better Care" Program - A Hospital Risk-Share Program for Blood Transfusion Related Cost Reduction with SpHb®, and $30 SpHb Sensor Price 6Masimo Announces "Better Care" Program - A Hospital Risk-Share Program for Blood Transfusion Related Cost Reduction with SpHb®, and $30 SpHb Sensor Price 7
... Unique product designed for LASIK surgery and ... irrigate the corneal interface and/or stromal bed. ... flap and helps elevate the flap edge. ... 7/8in (.50 x 22mm) Formed 7mm from ...
... product designed for LASIK surgery and ... to irrigate the corneal interface and/or ... insertion under the flap and helps ... provide multi-directional irrigation. 23G x 7/8in ...
... Unique product designed for LASIK surgery ... Designed to irrigate the corneal interface ... easy insertion under the flap and ... ports provide multi-directional irrigation. 21G x ...
For injecting viscoelastic to all meridians of the anterior chamber and to coat intraocular lenses. 20G x 7.8in (.90 x 22mm)....
Medicine Products: