Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Elavil(R)
Date:6/30/2008

DETROIT, June 30 /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 Applications (ANDAs) for Amitriptyline Hydrochloride USP Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.

Amitriptyline Hydrochloride is an antidepressant. Its use is indicated to treat symptoms of depression. According to IMS Data, for the twelve months ended March, 2008, Amitriptyline Hydrochloride USP Tablets had annual generic sales of approximately $16 million. It is marketed under the brand name of Elavil(R), a registered trademark of AstraZeneca.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to gain these approvals from the FDA. Our focus continues to be working towards expanding our product portfolio effectively, including products that are already available generically in the market that potentially can offer additional measurable value."

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©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
2. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
3. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
4. Caraco Pharmaceutical Laboratories Ltd. Announces Tentative FDA Approval for Generic Zyrtec Chewable(R)
5. Caraco Pharmaceutical Laboratories Ltd. Reports Record Net Sales for the Second Quarter and First Six Months of Fiscal 2008
6. Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lamictal(R)
7. Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lexapro(R)
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Norvasc(R)
9. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Zyrtec Allergy Tablets(R) and Zyrtec Hives Relief Tablets(R)
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Childrens Zyrtec(R) Chewable Tablets for Allergy Relief and Childrens Zyrtec(R) Chewable Tablets for Hives Relief
11. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Metaglip(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... ... 12, 2016 , ... According to an article published February 4th ... significant portion of hernia repairs throughout the United States. Commenting on this article, Beverly ... that this trend has not only been expected, but it seems to be a ...
(Date:2/12/2016)... Boca Raton, FL (PRWEB) , ... February 12, ... ... nation’s largest non-profit organization devoted exclusively to funding innovative lymphoma research and serving ... patient services – hosted over 250 members of South Florida’s philanthropic community at ...
(Date:2/12/2016)... ... February 12, 2016 , ... As a former television executive, owner Tal Rabinowitz ... no time to decompress, Rabinowitz found herself drawn to a casual meditation class while ... on her life, implementing a 20-minute-per-day meditation practice with her team. After her tenure ...
(Date:2/12/2016)... Miami, FL (PRWEB) , ... February 12, 2016 ... ... Workspace as a Service (WaaS), today announced the integration of Clarity Intelligence Platform ... itopia’s channel partners to offer real-time business intelligence (BI) to their small and ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... The Jones ... other communities across eastern Texas, is launching a cooperative charity drive with the Tarrant ... , Serving more than 50,000 individuals and families in need, the Tarrant County Food ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... , Feb. 11, 2016 ... Companion Diagnostics in Personalized Medicine and Cancer Therapy. ... - High-Growth Diagnostic Testing Markets. - Key Diagnostic ... - Molecular Diagnostics in Genetic Testing. - ... Diagnostics Markets. - Over-the-Counter Diagnostic Products World Markets. ...
(Date:2/11/2016)... FRANCISCO , Feb. 11, 2016  Kindred Biosciences, ... on saving and improving the lives of pets, today ... Section of the New Animal Drug Application (NADA) for ... pivotal field study (KB0120) of Zimeta for the control ... the Company. --> --> ...
(Date:2/11/2016)... Calif. , Feb. 11, 2016  NOIT™ Research ... a special "Gift of Change" campaign to assist needy ... For every such unit sold between February 10, 2016 ... unit to a needy family. The NOIT is an ... non/limited-verbal autistic individuals develop language skills. ...
Breaking Medicine Technology: