Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
Date:8/31/2007

DETROIT, Aug. 31 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Allopurinol Tablets USP, 100 mg and 300 mg (Allopurinol).

Allopurinol is indicated in the management of patients with signs and symptoms of primary or secondary gout, the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion are elevated. Our generic Allopurinol is the bioequivalent to Zyloprim(R), a registered trademark of Prometheus Laboratories, Inc. According to IMS Data, for the twelve months ended June 2007, Allopurinol generic and brand products (Zyloprim(R)) combined had annual sales of approximately $33 million.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to gain this approval from the FDA. Our focus continues to be working towards expanding our product line effectively, including products that are already available generically in the market that potentially can add measurable value. We plan to market this product to the generic pharmaceutical market immediately. This will bring our total product selection to 38 different products represented by 78 various strengths."

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or cheaper products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward- looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.


'/>"/>
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2007 PR Newswire.
All rights reserved

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:4/29/2017)... ... April 29, 2017 , ... TransDark is a set ... one video to the next without having to set a single keyframe in ... to enhance your video production. , TransDark features dynamic transitions that momentarily splits the ...
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... An April 24th article on ... stunning 180 pounds with the help of a weight loss surgery. The woman, declaring “I ... skin that have been left following her dramatic weight loss. Dr. Feiz & Associates notes ...
(Date:4/28/2017)... , ... April 28, 2017 , ... Beginning in 2017, ... their formulas. This begins with the popular ClearLungs Extra Strength formula. To ensure that ... the formula in the following ways:, , Removal of the ...
(Date:4/28/2017)... ... April 28, 2017 , ... Ushio America ... lamps offer an instant energy-saving solution for F32T8 fluorescent lamps on most instant-start ... ballasts. These 50,000 hour rated lamps utilize the existing electronic ballast, saving labor ...
(Date:4/28/2017)... ... April 28, 2017 , ... From ... College of Urgent Care Medicine will host industry leaders for the annual spring ... help those in the industry adapt to the issues currently affecting urgent care ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... 20, 2017  Cogentix Medical, Inc. (NASDAQ: CGNT), ... the Urology, Uro/Gyn and Gynecology markets with innovative ... has joined the Company as Senior Vice President, ... position, Mr. Keswani will report directly to ... "Our organization is delighted that Ash has joined ...
(Date:4/20/2017)... , April 20, 2017  RXi Pharmaceuticals Corporation ... therapeutics that address significant unmet medical needs, today ... the Company,s consumer product development program, based on ... Society for Investigative Dermatology (SID) 76 th ... and promote the sciences relevant to skin health ...
(Date:4/20/2017)... , April 20, 2017  AbbVie (NYSE: ... 99 percent (n=145/146) of chronic hepatitis C virus ... 5 or 6 and compensated cirrhosis (Child-Pugh A) ... (SVR 12 ) with its investigational, pan-genotypic regimen ... rates were seen following 12 weeks of G/P ...
Breaking Medicine Technology: