Generics

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:

BALTIMORE — The Food and Drug Administration has approved a generic drug for epilepsy made by Lupin Pharmaceuticals, the drug maker said.

Lupin announced the approval and launch of levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.

The drug is a generic version of UCB's Keppra XR, which had sales of about $161 million during the 12-month period ended in June, according to IMS Health.

DEERFIELD, Ill. — Walgreens, the Department of Health and Human Services, the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services on Tuesday announced the kick-off of the Million Hearts Initiative, a public and private sector initiative to help prevent 1 million heart attacks and strokes over five years.

HAYWARD, Calif. — Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

MORRISTOWN, N.J. — Watson Labs has begun shipping a drug designed to treat partial onset seizures in patients with epilepsy.

The drug maker said it launched levetiracetam extended-release tablets in the 500-mg and 750-mg strengths. The drug is a generic version of UCB's Keppra XR. The drug is indicated to treat patients ages 16 years and older.

Watson said it began shipping the drug on Tuesday following approval of its abbreviated new drug application from the Food and Drug Administration.

AMITYVILLE, N.Y. — First-quarter net sales for Hi-Tech Pharmacal's generic pharmaceuticals business increased by 52% to nearly $49 million, the drug maker reported.

Hi-Tech Pharmacal attributed the spike to stronger sales of fluticasone propionate nasal spray.

For the three months ended July 31, the company recorded net income from continuing operations of $13.8 million, or $1.05 per diluted share, a 58% rise compared with net income from the year-ago period.

Overall, net sales for Hi-Tech Pharmacal jumped 43% during its first quarter to $56.2 million.

While it has been a boon to elderly Americans, Medicare Part D includes a complicating factor that has proven to be a headache.


Despite its seemingly charming name, the doughnut hole has proven to be a headache for many seniors. Also known as the Medicare Part D coverage gap, the doughnut hole is when drug costs reach a point when the patient becomes responsible for the entire cost, and Medicare doesn’t pay for them again until they reach the catastrophic-coverage threshold. The hole and threshold change from year to year.


At press time, Hurricane Irene was slowly barreling toward the East Coast and threatening the area with a deluge that prompted cities to shut down and had store shelves wiped clean.