Content about Impax Labs

May 13, 2013

A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

February 11, 2013

Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

November 1, 2012

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.

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.

October 9, 2012

Drug maker Dr. Reddy’s Labs has launched a generic antibiotic drug, the company said. The India-based company announced the launch of amoxicillin tablets, capsules and oral suspension.

Dr. Reddy's launches antibiotics

October 5, 2012

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.

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.

September 14, 2012

Two generic drug makers have settled with a subsidiary of Johnson & Johnson and another company concerning a drug used to treat attention deficit hyperactivity disorder.

HAYWARD, Calif. — Two generic drug makers have settled with a subsidiary of Johnson & Johnson and another company concerning a drug used to treat attention deficit hyperactivity disorder.

Impax Labs and Teva Pharmaceuticals USA had settled a patent infringement suit with Janssen Pharmaceuticals and Alza over Concerta (methylphenidate hydrochloride) extended-release tablets in the 18-mg, 27-mg, 36-mg and 54-mg strengths.

September 4, 2012

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

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.

June 29, 2012

One of Impax Labs' top executives is leaving the company, the drug maker announced Friday.

HAYWARD, Calif. — One of Impax Labs' top executives is leaving the company, the drug maker announced Friday.

Impax said EVP finance and CFO Arthur Koch would resign to pursue other opportunities. VP finance Bryan Reasons has been appointed acting CFO as the company searches for a successor to Koch.

April 12, 2012

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

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.

March 26, 2012

Impax Labs has partnered with a pharmaceutical research, development, manufacturing and commercial operations company on a multiproduct agreement.

HAYWARD, Calif., and FORT COLLINS, Colo. — Impax Labs has partnered with a pharmaceutical research, development, manufacturing and commercial operations company on a multiproduct agreement.

Impax Labs and Tolmar will develop, supply and distribute alternative dosage form products. The products and terms of the agreement were not disclosed; however, Impax Labs president and CEO Larry Hsu said the new agreement "represents an ideal extension of [our] initial product agreement."

February 23, 2012

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

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.

February 1, 2012

Impax Pharmaceuticals said Wednesday that it obtained exclusive U.S. commercial rights to a drug for migraine headaches made by AstraZeneca.

HAYWARD, Calif. — Impax Pharmaceuticals said Wednesday that it obtained exclusive U.S. commercial rights to a drug for migraine headaches made by AstraZeneca.

December 21, 2011

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. — 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.

November 21, 2011

Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon's Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can't be controlled by other drugs.

November 1, 2011

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.

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.

September 13, 2011

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

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

September 6, 2011

Impax Labs has appointed a new president of its generic pharmaceutical division.

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.

August 31, 2011

Impax Labs has hit a roadblock in its attempts to market a generic pseudobulbar affect treatment.

HAYWARD, Calif. — Impax Labs has hit a roadblock in its attempts to market a generic pseudobulbar affect treatment.

Impax said that Avanir Pharmaceuticals, Avanir Holding Co. and the Center for Neurologic Study filed a patent infringement suit in the U.S. District Court of Delaware in connection with Impax's attempt to market a generic version of Nuedexta capsules (dextromethorphan hydrobromide and quinidine sulfate) in the 20-mg/10-mg strength.

July 26, 2011

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

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.

June 30, 2011

Impax Labs has agreed not to market a generic version of a drug designed to reduce blood sugar and cholesterol in tablet form until 2015.

HAYWARD, Calif. — Impax Labs has agreed not to market a generic version of a drug designed to reduce blood sugar and cholesterol in tablet form until 2015.

June 22, 2011

Impax Labs has expanded its senior management team with two appointments.

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.

June 6, 2011

The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

HAYWARD, Calif. — The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

June 3, 2011

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.

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.

May 23, 2011

The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.


SUPPLIER NEWS — The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.


May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

HAYWARD, Calif. — The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

Impax Pharmaceuticals, as the division is known, said it filed an investigational new drug application with the Food and Drug Administration for IPX159 and started a phase-1 study.