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)
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.
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).
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