Navigation Links
Qualitest Receives FDA Approval for Dexamethasone Elixir, USP, 0.5mg/ 5 mL and Orsythia™ Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.1 mg/0.02 mg)
Date:5/18/2011

HUNTSVILLE, Ala., May 18, 2011 /PRNewswire/ -- Qualitest Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved dexamethasone elixir, USP, 0.5mg/ 5 mL and Orsythia™ Tablets (levonorgestrel and ethinyl estradiol tablets, USP, 0.1 mg/0.02 mg).

Dexamethasone elixir is used to treat a variety of conditions including endocrine disorders, rheumatic disorders, and collagen diseases. Orsythia™ Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

The total IMS sales for dexamethasone elixir, USP, 0.5mg/ 5 mL and Orsythia™ Tablets (levonorgestrel and ethinyl estradiol tablets, USP, 0.1 mg/0.02 mg)for the 12-months ended March 31, 2011 are $4 million and $100 million, respectively.

About Qualitest

Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Pharmaceuticals (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics (www.endo.com).  

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements.  Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.


'/>"/>
SOURCE Qualitest Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Endo Pharmaceuticals Announces Agreement to Acquire Qualitest Pharmaceuticals for $1.2 Billion
2. Qualitest Pharmaceuticals Selects TrackWise® for Comprehensive Enterprise Quality and Document Management
3. Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 500 mg, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E and T023M10A and Phenobarbital Tablets, USP 32.4 mg, ND
4. Qualitest Receives FDA Approval for Emoquette™ (.15 mg Desogestrel and .03 mg Ethinyl Estradiol), an Oral Contraceptive for Prevention of Pregnancy
5. Qualitest Receives FDA Approval for Toresmide Tablets (Generic Demadex®) 5 mg, 10 mg, 20 mg, 100 mg, for the Treatment of Edema Associated with Congestive Heart Failure, Renal Disease, or Hepatic Disease
6. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
7. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
8. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
9. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
10. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
11. CryoCor Receives FDA Approval for Right Atrial Flutter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... VIEW, Calif. , Feb. 10, 2016 ... of a synergistic confluence of various technologies ... value propositions, previously unavailable. These opportunities create ... and convergence, in turn, drives the development ... entrepreneurial scenario is characterized by technology convergences, ...
(Date:2/10/2016)... , Feb. 10, 2016 Mast Therapeutics, ... novel, clinical-stage therapies for sickle cell disease and heart ... offering of 29,090,910 units at a price to the ... one share of the Company,s common stock and one ... stock at an exercise price of $0.42 per share. ...
(Date:2/10/2016)... 10, 2016 /PRNewswire/ - The President of New Venture ... release of an anti-radiation product from their Research ... in the treatment of cancer using radiation and ... assist in the healing of radiation burns, even ... protect only the healthy cells from radiation damage. ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... ... care communications company offering education, research and medical media, has launched ... working in infectious diseases. , As the all-inclusive resource for infectious disease ...
(Date:2/10/2016)... ... February 10, 2016 , ... MetLoop CEO Jay Southerland ... version at the International Roofing Expo in Orlando, Florida on February 17-19. , ... advanced weather technology in the hands of consumers, roofing contractors, manufacturers and distributors,” ...
(Date:2/10/2016)... (PRWEB) , ... February 10, 2016 , ... ... and Video Remote Interpreting (VRI) within Healthcare, recently partnered with Heart City ... interpreting (VRI). , For nearly 23 years, Heart City Health Center has provided ...
(Date:2/10/2016)... Huntington, NY (PRWEB) , ... February 10, 2016 ... ... web-based compliance tracking solution, The Guard, to associations of medical professionals throughout the ... HIPAA compliance, including security risk assessments, policies and procedures, employee training, regulatory updates, ...
(Date:2/10/2016)... ... ... Emergency rooms provide emergency care to stabilize critical health issues, but emergency dental ... at risk of losing a tooth or their smiles. Dr. Marine Martirosyan, dentist ... include:, , Avulsed or knocked-out teeth , Dislodged ...
Breaking Medicine News(10 mins):