Content about Impax Labs

NEW YORK – Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

WASHINGTON — The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax Labs and Teva Pharmaceuticals USA, is not therapeutically equivalent to Wellbutrin XL in the 300-mg strength.

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with a subsidiary of Sanofi regarding generic versions of two drugs for dialysis patients, Impax said Tuesday.

Impax announced a settlement with Genzyme concerning generic versions of Renvela (sevelamer carbonate) 800 mg tablets and 2.4 g and 0.8 g oral suspension and Renagel (sevelamer hydrochloride) tablets in the 400 mg and 800 mg strengths.

HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent protection on a drug used to treat postherpetic neuralgia, the company said Thursday.

Impax announced that it had filed a regulatory approval application with the Food and Drug Administration for gabapentin tablets, a generic version of Depomed's Gralise, in the 300-mg and 600-mg strengths.

HAYWARD, Calif. — The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

Impax Pharmaceuticals, the branded products division of Impax Labs, said it filed its NDA for the investigational drug IPX066, an extended-release capsule formulation of carbidopa-levodopa, for review in December 2011. IPX066 has been licensed to GlaxoSmithKline for countries outside the United States and Taiwan for development and marketing.

HAYWARD, Calif. — The branded subsidiary of Impax Labs has submitted a new drug application for its investigational idiopathic Parkinson's disease treatment to the Food and Drug Administration.

HAYWARD, Calif. — Drug maker Impax Labs reported sales of $119.8 million and profits of $20 million in third quarter 2011, according to an earnings report released Tuesday.

The latest sales figures represented a $12.2 million increase over third quarter 2010, while profits were $4.2 million higher.

HAYWARD, Calif. — Impax Labs has appointed a new president of its generic pharmaceutical division.

The drug maker said that Carole Ben-Maimon will be responsible for expanding the generic business. Recently, Ben-Maimon served as Qualitest Pharmaceuticals' SVP corporate strategy consulting. Additionally, she served as the chairman of the board of the Generic Pharmaceutical Association from 2000 to 2003.

Ben-Maimon will report to Impax's president and CEO Larry Hsu.

HAYWARD, Calif. — The branded drugs division of Impax Labs has finished enrolling patients in a late-stage trial of a drug for Parkinson’s disease.

Impax Pharmaceuticals said Tuesday that it had enrolled patients in ASCEND-PD, a phase-3 trial of IPX066 that will compare the drug with carbidopa-levodopa and entacapone in patients with advanced Parkinson’s. IPX066 is an extended-release formulation of carbidopa-levodopa in capsule form.

HAYWARD, Calif. — Impax Labs has expanded its senior management team with two appointments.

The generic drug maker said that Mark Fitch has joined the company as SVP operations, while Jeff Nornhold will become SVP quality affairs. Fitch, who joins Impax from Nycomed US, brings more than 35 years of pharmaceutical experience to his role. Nornhold, who most recently served as VP quality operations at drug maker Watson, is a 20-year pharmaceutical industry veteran.

Both Fitch and Nornhold will report to Impax president and CEO Larry Hsu.

HAYWARD, Calif. — Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.

Impax said Friday that Pfizer filed a patent infringement suit in the U.S. District Court of the District of New Jersey in connection with Impax’s attempt to market a generic version of Detrol (tolterodine tartrate) immediate-release tablets in the 1-mg and 2-mg strengths. The drug is used to treat overactive bladder and urinary incontinence.