Printer Friendly
The Free Library
14,573,512 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Able Laboratories Receives FDA Approval for Promethazine Hydrochloride Suppositories, USP 50mg; First AB-Rated Generic Version of Wyeth-Ayerst Phenergan 50mg Suppository.


Business Editors/Health/Medical Writers

SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--Feb. 28, 2003

Able Laboratories, Inc. (Nasdaq:ABRX) (BSE See Bombay Stock Exchange.

BSE

See Boston Stock Exchange (BSE).
:AAB), today announced that it has received Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) approval for its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar  (ANDA) for Promethazine Hydrochloride Suppositories suppositories,
n.pl solid capsules made of materials that melt at body temperature and are used to deliver medicinal substances into the rectum.
, USP USP - unique sales point  50mg. This product is equivalent to Phenergan(R) Suppositories, USP 50mg of Wyeth-Ayerst Laboratories. The total market for Able's newly approved drug (used in the treatment of allergies, anaphylactic reaction, pre/post-operative sedation, nausea and vomiting Nausea and Vomiting Definition

Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth.
) is estimated to be approximately $7 million according to recent IMS data.

This represents the first generic AB-rated Promethazine Hydrochloride Suppository suppository /sup·pos·i·to·ry/ (su-poz´i-tor?e) an easily fusible medicated mass to be introduced into a body orifice, as the rectum, urethra, or vagina.

sup·pos·i·to·ry
n.
, USP 50mg available to the market.

Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Since March 2001, Able has received 24 ANDA approvals. Further information on Able may be found on the Company's web site, www.ablelabs.com.

Except for historical facts, the statements in this news release, as well as oral statements or other written statements made or to be made by Able Laboratories, Inc., are forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995 and involve risks and uncertainties. For example, statements about the Company's operations, capital-raising transactions and financial accounting, the current or expected market size for its products, the success of current or future product offerings, the research and development efforts and the Company's ability to file for and obtain U.S. Food and Drug Administration approvals for future products, are forward-looking statements. Forward-looking statements are merely the Company's current predictions of future events. The statements are inherently uncertain, and actual results could differ materially from the statements made herein. There is no assurance that the Company will achieve the sales levels that will make its operations profitable or that ANDA filings and approvals will be completed and obtained as anticipated. For a description of additional risks, and uncertainties, please refer to the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2001 and its Form 10-Q for the nine months ended September 30, 2002. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments.
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Feb 28, 2003
Words:366
Previous Article:Corporate Profile for Con Edison Communications, dated February 28, 2003.
Next Article:David Fried Recommends the Following Issues: OfficeMax, Activision, Barnes & Noble and Toys R Us.
Topics:



Related Articles
Norplant users detail pain, losses suffered from contraceptive.
Hi-Tech Pharmacal receives FDA approval to market generic form of phenergan with dextromethorphan syrup.
Hi-Tech Pharmacal Receives FDA Approval to Market Generic Form of Phenergan with Codeine Phosphate Syrup.
Hi-Tech Pharmacal Receives FDA Approval to Market Generic Form of Phenergan Syrup.
Able Laboratories Receives FDA Approval for Prochlorperazine Suppositories USP, 2.5 Mg, 5 Mg and 25 Mg.
Able Laboratories Receives FDA Approval for Butalbital, Acetaminophene, Caffeine Tablets; Generic Version of Fioricet With Estimated Total Market of...
Able Laboratories Receives FDA Approval for the Generic Version of Esgic Plus Tablets.
Able Laboratories Receives ANDA Approval for Tramadol Hydrochloride Tablets; Generic Version to be Marketed by IVAX Pharmaceuticals.
FDA APPROVES TEVA'S ANDA TO MARKET GENERIC VERSION OF ZOCOR.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles