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Last updated on April 20, 2014 at 13:20 EDT

Latest Qualitest Stories

2013-10-07 08:26:23

WOODCLIFF LAKE, N.J., Oct. 7, 2013 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for clonidine hydrochloride (HCl) 0.1 mg extended-release (ER) tablets. Clonidine HCl ER is the generic version of Concordia's Kapvay(®) and is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to...

2013-02-28 16:28:35

MALVERN, Pa., Feb. 28, 2013 /PRNewswire/ -- Total quarterly revenues of $801 million, comparable to prior year. Fourth quarter reported diluted (GAAP) loss per share of $6.35 includes a $640 million non-cash asset impairment charge related primarily to goodwill and other intangible assets attributable to the company's American Medical Systems (AMS) segment. Fourth quarter adjusted diluted EPS of $1.62 increased by 16 percent versus prior year; Full year 2012 adjusted diluted EPS of...

2012-12-20 08:26:34

PITTSBURGH, Dec. 20, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its Mylan Institutional business is conducting a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573). The three lots were manufactured by Qualitest Pharmaceuticals, and Mylan Institutional repackaged and distributed the product in unit dose (CD100) under the UDL Laboratories, Inc. (n/k/a...

2012-12-06 20:22:11

HUNTSVILLE, Ala., Dec. 6, 2012 /PRNewswire/ -- Qualitest, a subsidiary of Endo Health Solutions, (Nasdaq: ENDP) today issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. This includes product with the following NDC numbers and lot numbers beginning with the letter "C". NDC Number Bottle Count ---------- ------------ 0603-3888-16 30 ------------...

2012-11-05 08:31:13

CHADDS FORD, Pa., Nov. 5, 2012 /PRNewswire/ -- Total quarterly revenues of $750 million, decreased 1 percent versus prior year Qualitest quarterly net sales increase by 12 percent versus prior year Reformulated Version of OPANA(®) ER with INTAC(® )Technology Designed to be Crush-Resistant Accounts for more than 90 Percent of OPANA ER Total Prescription Volume Company now expects adjusted diluted EPS in the range of $5.00 to $5.10; Now expects reported diluted (GAAP) EPS in the...

2012-10-04 02:26:00

CHADDS FORD, Pa., Oct. 4, 2012 /PRNewswire-FirstCall/ -- Highlights long-term growth drivers and investment attributes of the company Endo updates 2012 performance, reaffirms full year 2012 revenues of $3.05 to $3.175 billion and adjusted diluted EPS in the range of $5.00 to $5.20; expects reported or GAAP diluted EPS of $1.37 to $1.57 Company expects 2013 revenue of $3.0 to $3.2 billion and adjusted diluted EPS of $5.20 to $5.40; expects reported or GAAP diluted EPS of $3.17 to $3.37...

2012-08-07 02:20:27

CHADDS FORD, Pa., Aug 7, 2012 /PRNewswire/ -- Total quarterly revenues of $785 million, increased 29 percent versus prior year Qualitest grows quarterly sales by 20 percent versus prior year Commercial conversion of OPANA(®) ER to new formulation designed to be crush-resistant completed during second quarter Company maintains adjusted diluted EPS in the range of $5.00 to $5.20; Now expects reported diluted (GAAP) EPS in the range of $1.07 to $1.27 Company now expects revenues...

2012-08-06 02:25:58

HUNTSVILLE, Ala., Aug. 6, 2012 /PRNewswire/ -- Qualitest Pharmaceuticals today confirmed that it has launched a generic version of Singulair (montelukast sodium) Tablets and Chewable Tablets, following the expiration of the last patent that provides Merck U.S. market exclusivity. Qualitest will begin shipping the product immediately. Montelukast Sodium Tablets are labeled for use in treating symptoms of asthma and allergic rhinitis. The total combined sales for Montelukast...

2012-07-25 02:30:39

HUNTSVILLE, Ala., July 25, 2012 /PRNewswire-FirstCall/ -- Qualitest Pharmaceuticals today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam extended-release tablets, 500mg and 750mg, the generic equivalent of UCB's Keppra XR®. The total combined sales for Levetiracetam extended-release tablets, 500mg and 750mg, in the U.S. for the 12 months ending May 31, 2012, were...

2012-05-01 02:30:58

CHADDS FORD, Pa., May 1, 2012 /PRNewswire/ -- Total quarterly revenues of $691 million, increased 23 percent versus prior year; Driven by full quarter addition of AMS as well as Qualitest revenue growth of 8 percent. Adjusted diluted EPS of $0.87, aligned with prior guidance of below $0.90. Reported quarterly diluted loss per share of $0.75 versus earnings per share of $0.46 for prior year. Management expects return to year-over-year adjusted diluted earnings growth for remainder of...