Content about Qualitest Pharmaceuticals

July 26, 2012
Qualitest gets FDA OK for generic Keppra XR

Qualitest Pharmaceuticals announced that it has received approval from the Food and Drug Administration for its generic version of an epilepsy treatment.

HUNTSVILLE, Ala. — Qualitest Pharmaceuticals announced that it has received approval from the Food and Drug Administration for its generic version of an epilepsy treatment.

The drug maker said its abbreviated new drug application for levetiracetam extended-release tablets, in the 500-mg and 750-mg strength, was approved. The drug is a generic version of UCB's Keppra XR.

Total combined sales for levetiracetam extended-release tablets were approximately $124.8 million for the 12 months ended in May, according to IMS Health data.

November 29, 2011
Qualitest receives FDA approval for Myzilra tablets

The Food and Drug Administration has approved a new oral contraceptive manufactured by Endo subsidiary Qualitest Pharmaceuticals.

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a new oral contraceptive manufactured by Endo subsidiary Qualitest Pharmaceuticals.

The generic drug maker announced approval of Myzilra tablets (levonorgestrel and ethinyl estradiol tablets, USP) in the 0.05-mg/0.03-mg, 0.075-mg/0.04-mg and 0.125-mg/0.03-mg (28-day triphasic regimen) strengths.

U.S. sales for Myzilra tablets totaled approximately $34.4 million for the 12 months ended Sept. 30, according to IMS Health.

November 14, 2011
FDA approves Qualitest painkiller

The Food and Drug Administration has approved a generic drug for treating pain.

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a generic drug for treating pain.

Qualitest Pharmaceuticals announced Monday the approval of acetaminophen and codeine phosphate oral solution in the 120-mg/12-mg-per-5-mL strength.

Sales for acetaminophen and codeine phosphate oral solution for $4.3 million during the 12-month period ended in September, according to IMS Health.

September 16, 2011
Endo subsidiary announces nationwide recall of birth control

Qualitest Pharmaceuticals, an Endo Pharmaceuticals subsidiary, issued a voluntary, nationwide recall of multiple lots of oral contraceptives at the retail level.

HUNTSVILLE, Ala. — Qualitest Pharmaceuticals, an Endo Pharmaceuticals subsidiary, issued a voluntary, nationwide recall of multiple lots of oral contraceptives at the retail level.

Qualitest said it recalled lots of the following birth control pills due to a packaging error, whereby select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible. This error, the drug maker said, could leave women without adequate contraception and at risk for unintended pregnancy:

March 24, 2011
Qualitest's toresmide tablets approved by FDA

The Food and Drug Administration has approved a generic drug for cardiovascular disease made by Qualitest Pharmaceuticals.

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a generic drug for cardiovascular disease made by Qualitest Pharmaceuticals.

Qualitest announced Thursday the approval of toresmide tablets in the 5-mg, 10-mg, 20-mg and 100-mg strengths.

The drug is used to treat edema associated with congestive heart failure, kidney disease or hepatic disease, and also for hypertension.

December 1, 2010
Endo completes Qualitest acquisition

Endo Pharmaceuticals has finished its acquisition of Qualitest Pharmaceuticals for $1.2 billion, Endo said Wednesday.

CHADDS FORD, Pa. — Endo Pharmaceuticals has finished its acquisition of Qualitest Pharmaceuticals for $1.2 billion, Endo said Wednesday.

Endo had agreed to buy Qualitest, a privately owned manufacturer of generic drugs, on Dec. 28.

September 27, 2010
Endo boosts portfolio with Qualitest acquisition

Endo Pharmaceuticals will acquire generic drug maker Qualitest Pharmaceuticals for $1.2 billion, Endo said Tuesday....

CHADDS FORD, Pa. Endo Pharmaceuticals will acquire generic drug maker Qualitest Pharmaceuticals for $1.2 billion, Endo said Tuesday.

Endo said the purchase of privately owned Qualitest would expand its offering of branded drugs, generics, devices and services in areas such as pain and urology. Qualitest is the sixth largest generic drug company in the United States, as measured by prescriptions filled.