Content about Pharmaceutical companies

March 28, 2012

Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.

NEW YORK — Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.

Dr. Reddy's Labs, Teva and Mylan announced Wednesday the launch of their respective versions of quetiapine fumarate tablets, generic formulations of AstraZeneca's Seroquel, in strengths ranging from 25 mg to 400 mg.

March 22, 2012

GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.

SILVER SPRING, Md. — GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.

March 22, 2012

Teva Pharmaceutical Industries Ltd. announced on March 14 that it has commenced commercial launch of escitalopram oxalate tablets, the company’s generic version of Forest Laboratories’ depression and generalized anxiety disorder treatment Lexapro tablets.

Teva Pharmaceutical Industries Ltd. announced on March 14 that it has commenced commercial launch of escitalopram oxalate tablets, the company’s generic version of Forest Laboratories’ depression and generalized anxiety disorder treatment Lexapro tablets.

The branded product had annual sales of approximately $2.9 billion in the United States, based on IMS sales data. As the first company to file an abbreviated new drug application containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.

March 21, 2012

A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

PHILADELPHIA — A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

GSK announced that the FDA Oncologic Drugs Advisory Committee voted 11-2 that clinical trial data indicated a favorable risk-benefit profile of the drug Votrient (pazopanib) in patients with advanced soft-tissue sarcoma who have received chemotherapy. The drug is already approved for treating the kidney cancer renal cell carcinoma.

March 21, 2012

The Food and Drug Administration has approved Watson's generic version of a drug used to prevent and treat osteoporosis in post-menopausal women, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved Watson's generic version of a drug used to prevent and treat osteoporosis in post-menopausal women, the company said.

Watson announced the FDA's approval of ibandronate tablets in the 150-mg strength, a generic version of Genentech's Boniva. Watson plans to launch its version in second quarter 2012.

March 21, 2012

Watson Pharmaceuticals is looking to acquire Actavis, according to published reports.

NEW YORK — Generic drug maker Watson Pharmaceuticals is looking to acquire Actavis, according to published reports.

News media reported Wednesday that U.S.-based Watson was close to taking over Switzerland-based Actavis for $6.6 to $7.3 billion. Actavis, also a major manufacturer of generic drugs, was formerly based in Iceland and moved its headquarters to Switzerland last year.

March 21, 2012

Israel-based Teva Pharmaceutical Industries is switching stock exchanges, the company said.

JERUSALEM — Israel-based Teva Pharmaceutical Industries is switching stock exchanges, the company said.

The world's largest generic drug manufacturer — and increasingly a player in branded and specialty drugs — announced Wednesday that it would transfer the listing of its shares from the Nasdaq to the New York Stock Exchange, with plans to start trading on the NYSE on May 30 under its current ticker symbol, "TEVA."

March 19, 2012

Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.

PARSIPPANY, N.J. — Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.

Watson, through a subsidiary, filed with the Food and Drug Administration for approval of niacin extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Abbott's Niaspan.

March 15, 2012

A drug under investigation by Teva Pharmaceutical Industries and Active Biotech reduced symptoms and progression of disease in patients with multiple sclerosis, according to results of a late-stage clinical trial.

JERUSALEM — A drug under investigation by Teva Pharmaceutical Industries and Active Biotech reduced symptoms and progression of disease in patients with multiple sclerosis, according to results of a late-stage clinical trial.

Teva and Active announced the publication of results of the phase-3 "Allegro" study of oral laquinimod in the March 15 issue of the New England Journal of Medicine. The study was conducted in 24 countries and enrolled 1,106 patients with MS who received 0.6 mg of laquinimod per day or placebo.

March 14, 2012

The Food and Drug Administration has approved the first generic version of an antidepressant made by Forest Labs, the agency said Wednesday.

SILVER SPRINGS, Md. — The Food and Drug Administration has approved the first generic version of an antidepressant made by Forest Labs, the agency said Wednesday.

The FDA announced the approval of a generic version of Lexapro (escitalopram) made by Teva Pharmaceutical Industries in the 5-mg, 10-mg and 20-mg strengths. The drug is used to treat depression and generalized anxiety disorder in adults.

March 12, 2012

Drug maker Watson Pharmaceuticals has started a late-stage trial of a drug made to treat benign tumors of the uterus, the company said Monday.

PARSIPPANY, N.J. — Drug maker Watson Pharmaceuticals has started a late-stage trial of a drug made to treat benign tumors of the uterus, the company said Monday.

Watson announced the initiation of a phase-3 trial of Esmya (ulitristal acetate) in women who have anemia due to uterine leimyomas, also known as uterine fibroids, which causes benign solid tumors that can lead to excessive menstrual bleeding, anemia and pain and may require surgery. Watson is developing the drug under a licensing agreement with Gedeon Richter.

March 9, 2012

The Food and Drug Administration has approved a version of a drug made by Teva that includes a dose counter, the drug maker said.

NORTH WALES, Pa. — The Food and Drug Administration has approved a version of a drug made by Teva that includes a dose counter, the drug maker said.

Teva announced the approval of the inhaled drug ProAir HFA (albuterol sulfate) with a dose counter for treating bronchospasm with reversible obstructive airway disease and preventing exercise-induced bronchospasm in patients ages 4 years and older. The dose counter is designed to help patients and caregivers keep track of the number of doses in the canister.

March 8, 2012

A pharmacy benefit manager and the U.S. subsidiary of a German drug maker have made a deal concerning a drug for multiple sclerosis.

ST. PAUL, Minn. — A pharmacy benefit manager and the U.S. subsidiary of a German drug maker have made a deal concerning a drug for multiple sclerosis.

March 7, 2012

A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said Wednesday.

INDIANAPOLIS — A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said Wednesday.

The two companies announced the availability of Jentadueto (linagliptin and metformin hydrochloride). The Food and Drug Administration approved the drug on Jan. 30.

March 6, 2012

The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

Merck said the agency issued a complete response letter for its regulatory approval application for a drug that would combine the cholesterol drug Zetia (ezetimibe) with atorvastatin, the active ingredient in Pfizer's Lipitor. A complete response letter means that the FDA cannot approve a drug application in its current form.

March 5, 2012

Indian drug maker Dr. Reddy's has launched a drug designed to treat bipolar disorder and schizophrenia, the company said.

HYDERABAD, India — Indian drug maker Dr. Reddy's has launched a drug designed to treat bipolar disorder and schizophrenia, the company said.

The company announced the launch of ziprasidone hydrochloride capsules in the 20-mg, 40-mg, 60-mg and 80-mg strengths.

The drug is a generic version of Pfizer's Geodon, which had sales of $1.34 billion in 2011, according to IMS Health.

March 5, 2012

A drug under development by Teva Pharmaceutical Industries appears safe and effective in treating allergies, according to results of a late-stage clinical trial released Monday.

JERUSALEM — A drug under development by Teva Pharmaceutical Industries appears safe and effective in treating allergies, according to results of a late-stage clinical trial released Monday.

Teva said a 529-patient phase-3 trial of Qnasl (beclomethasone dipropionate) nasal aerosol showed the drug produced a "significant" improvement in patients with seasonal and perennial allergies. Patients received either 320 mcg of Qnasl or a placebo.

March 2, 2012

A generic drug maker has launched its version of an Abbott Labs drug.

JERUSALEM — A generic drug maker has launched its version of an Abbott Labs drug.

Teva Pharmaceutical Industries said it launched progesterone capsules in the 100-mg and 200-mg strengths, a generic version of Prometrium.

Prometrium is indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogen tablets. The drug also is indicated for use in secondary amenorrhea.

For the 12 months ended Jan. 31, Prometrium had sales of approximately $198 million, according to IMS Health data.

February 28, 2012

The U.S. unit of Indian generic drug maker Glenmark is recalling a generic contraceptive drug, the company said.

NEW YORK — The U.S. unit of Indian generic drug maker Glenmark is recalling a generic contraceptive drug, the company said.

Glenmark Generics USA announced the recall of seven lots, imported from India, of norgestimate and ethinyl estradiol tablets in the 0.18-mg/0.035-mg, 0.215-mg/0.035-mg and 0.25-mg/0.035-mg strengths. The company said a packaging error resulted in blister packs being rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date visible only on the outer pouch.

February 24, 2012

Generic drug maker Hospira has joined the country's largest lobby for the generic drug industry, the company said.

LAKE FOREST, Ill. — Generic drug maker Hospira has joined the country's largest lobby for the generic drug industry, the company said.

Hospira, which specializes in generic injectables and infusion technology, announced that it had joined the Generic Pharmaceutical Association. In addition to generic pharmaceuticals, the company also makes biosimilars for the European market.

February 24, 2012

Generic drug maker Par Pharmaceutical has completed its acquisition of an Indian drug company, Par said.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical has completed its acquisition of an Indian drug company, Par said.

Par announced that it had completed its $20.5 million acquisition of Chennai, India-based Edict Pharmaceuticals.

Edict specializes in oral solid drugs and currently has 11 regulatory approval applications under review at the Food and Drug Administration.


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February 23, 2012

The president of one of the world's largest generic drug manufacturers will serve as chairman of the Generic Pharmaceutical Association, the organization said Thursday.

WASHINGTON — The president of one of the world's largest generic drug manufacturers will serve as chairman of the Generic Pharmaceutical Association, the organization said Thursday.

February 21, 2012

A division of Pfizer is asserting that it incurred nearly $1 billion in damages related to the launch of generic versions of one of its drugs.

MUMBAI, India — A division of Pfizer is asserting that it incurred nearly $1 billion in damages related to the launch of generic versions of one of its drugs.

In a lawsuit filed in the U.S. District Court for the District of New Jersey against Sun Pharmaceutical Industries and Teva Pharmaceutical Industries, Wyeth Pharmaceuticals said it estimated that it suffered damages of $960 million from Sun's and Teva's launches of generic versions of the gastroesophageal reflux disease drug Protonix (pantoprazole).

February 21, 2012

Pfizer has signed a deal worth more than $500 million with a Chinese drug maker to make generic drugs for China and other markets, the companies said.

NEW YORK — Pfizer has signed a deal worth more than $500 million with a Chinese drug maker to make generic drugs for China and other markets, the companies said.

Pfizer announced the joint venture with Zhejiang Hisun Pharmaceutical to develop, manufacture and commercialize generic drugs. Hisun will invest $295 million into the venture — called Hisun Pfizer Pharmaceutical Co. — and own a 51% stake, while Pfizer will invest $250 million and own 49%.

February 17, 2012

A specialty pharmacy provider has begun selling a drug made by Pfizer for treating kidney cancer.

ALTAMONTE SPRINGS, Fla. — A specialty pharmacy provider has begun selling a drug made by Pfizer for treating kidney cancer.

The company announced that it had launched Inlyta (axitinib), which the Food and Drug Administration approved last month for treating renal cell carcinoma in patients with advanced disease for whom first-line systemic therapy has failed. According to the American Cancer Society, 60,000 people in the United States are diagnosed with the disease each year, and 13,000 die.