Content about Teva Pharmaceutical Industries

October 26, 2012
FDA approves Teva's Synribo for blood and bone marrow cancer

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.

October 9, 2012
NewsBytes — Chain Pharmacy, 10/15/12

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
FDA issues new guidelines for budeprion XL in the 300-mg strength

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 18, 2012
Mergers among generics cos. on the rise

Over the last few years of DSN’s coverage of the impending patent cliff and how it would affect the generic drug industry, IMS Health VP industry relations Doug Long predicted that the gradual commoditization of primary care drugs — long the lifeblood of generic drug makers — would lead to consolidation of the industry.


Over the last few years of DSN’s coverage of the impending patent cliff and how it would affect the generic drug industry, IMS Health VP industry relations Doug Long predicted that the gradual commoditization of primary care drugs — long the lifeblood of generic drug makers — would lead to consolidation of the industry.


September 18, 2012
NewsBytes — Generics, 9/24/12

Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


NEW YORK — Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


September 14, 2012
Impax, Teva settle with J&J, Alza over generic ADHD drug

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.

August 30, 2012
FDA approves Teva biosimilar

The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

JERUSALEM — The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

August 17, 2012
Teva launches authorized generic Actos

Teva Pharmaceutical Industries announced the launch of an authorized generic of a Type 2 diabetes drug.

JERUSALEM — Teva Pharmaceutical Industries announced the launch of an authorized generic of a Type 2 diabetes drug.

The company launched pioglitazone hydrochloride tablets in the 15-mg, 30-mg and 45-mg strengths. The drug is a generic version of Takeda Pharmaceuticals' Actos.

Annual sales of Actos in the United States were approximately $2.7 billion for the 12-month period ended in June, according to IMS sales data.

August 15, 2012
Teva launches generic chemotherapy drug

A division of Teva Pharmaceutical Industries has launched a generic chemotherapy drug, the company said.

IRVINE, Calif. — A division of Teva Pharmaceutical Industries has launched a generic chemotherapy drug, the company said.

Teva Health Systems announced the introduction of oxaliplatin injection in the 50-mg and 100-mg strengths.

The drug is a generic version of Sanofi's Eloxatin, which had sales of $1.7 billion during the 12-month period ended in June, according to IMS Health.

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August 15, 2012
Watson sues FDA over generic Actos

Watson Pharmaceuticals is suing the Food and Drug Administration, alleging that an agency decision would improperly delay its release of a generic drug for diabetes, the company said Wednesday.

PARSIPPANY, N.J. — Watson Pharmaceuticals is suing the Food and Drug Administration, alleging that an agency decision would improperly delay its release of a generic drug for diabetes, the company said Wednesday.

August 13, 2012
FDA accepts Teva contraceptive pill application

The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

FRAZER, Pa. — The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.

Teva Women's Health, part of Israeli drug maker Teva Pharmaceutical Industries, announced the FDA's acceptance of its application for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol), which the company called the first ascending-dose, extended regimen oral contraceptive for preventing pregnancy.

August 10, 2012
Mylan launches generic sleep disorder, bipolar disorder drugs

Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

PITTSBURGH — Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

The generic drug maker announced the launch of modafinil tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Provigil, made by Cephalon — a company that Teva Pharmaceutical Industries acquired last year — and used to treat narcolepsy, obstructive sleep apnea and shift work disorder.

August 8, 2012
Teva, Active Biotech plan third MS drug trial

Drug makers Teva Pharmaceutical Industries and Active Biotech will start a third late-stage clinical trial of an experimental drug for treating multiple sclerosis, the companies said Wednesday.

JERUSALEM — Drug makers Teva Pharmaceutical Industries and Active Biotech will start a third late-stage clinical trial of an experimental drug for treating multiple sclerosis, the companies said Wednesday.

Israel-based Teva and Sweden-based Active Biotech said they would start a phase-3 trial of laquinimod for relapsing-remitting multiple sclerosis, also known as RRMS, following an agreement with the Food and Drug Administration.

August 6, 2012
FDA approves generic versions of asthma, allergy drug

The Food and Drug Administration has approved several generic versions of a drug used to treat asthma and allergies, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved several generic versions of a drug used to treat asthma and allergies, the agency said Friday.

The FDA announced the approval of montelukast sodium, a drug indicated for controlling asthma symptoms and relieving indoor and outdoor allergies.

The drug is a generic version of Merck's Singulair, which had sales of $4.6 billion in 2011, according to IMS Health.

August 2, 2012
Teva names two new executives

Teva Pharmaceutical Industries has named Carlo De Notaristefani as president and CEO of global operations and Aharon "Arik" Yaari as EVP community and institutional affairs, the Israeli drug maker said Thursday.

JERUSALEM — Teva Pharmaceutical Industries has named Carlo De Notaristefani as president and CEO of global operations and Aharon "Arik" Yaari as EVP community and institutional affairs, the Israeli drug maker said Thursday.

The company said De Notaristefani and Yaari would report directly to Teva president and CEO Jeremy Levin.

July 18, 2012
Teva launches ADHD drug

Teva Pharmaceuticals has introduced a generic drug for treating attention deficit hyperactivity disorder, the company said.

NORTH WALES, Pa. — Teva Pharmaceuticals has introduced a generic drug for treating attention deficit hyperactivity disorder, the company said.

Teva announced the launch of methylphenidate hydrochloride extended-release capsules in the 20-mg, 30-mg and 40-mg strength. The drug, a generic version of Novartis' Ritalin, is available in 100-pill bottles.

June 25, 2012
Federal court rules against Mylan in MS drug case

A federal court has ruled against Mylan in a case filed by Teva Pharmaceutical Industries over a drug to treat multiple sclerosis.

PITTSBURGH — A federal court has ruled against Mylan in a case filed by Teva Pharmaceutical Industries over a drug to treat multiple sclerosis.

The U.S. District Court for the Southern District of New York ruled Monday that Mylan's proposed generic version of the drug Copaxone (glatiramer acetate) infringed Teva's patents.

Mylan responded that it was "disappointed" by the decision and would appeal once it had the opportunity to review it in full.

May 31, 2012
Teva makes the switch from NASDAQ to NYSE

Teva Pharmaceutical Industries has transferred its stock listing from NASDAQ to the New York Stock Exchange, the drug maker said Wednesday.

NEW YORK — Teva Pharmaceutical Industries has transferred its stock listing from NASDAQ to the New York Stock Exchange, the drug maker said Wednesday.

The company began trading on the NYSE under the ticker symbol "TEVA." On hand Wednesday to ring the Opening Bell and celebrate the company's first day of trading on NYSE were Teva's new president and CEO Jeremy Levin, as well as board chairman Phillip Frost, CFO Eyal Desheh, Teva Americas CEO William Marth and employees from Teva's businesses around the world.

May 30, 2012
FDA warns consumers, healthcare professionals about fake Adderall

A counterfeit version of a Teva Pharmaceutical Industries attention deficit hyperactivity disorder and narcolepsy drug is circulating online, regulators warned Tuesday.

SILVER SPRING, Md. — A counterfeit version of a Teva Pharmaceutical Industries attention deficit hyperactivity disorder and narcolepsy drug is circulating online, regulators warned Tuesday.

The Food and Drug Administration issued a statement warning consumers and healthcare professionals that a fake versions of Adderall (dextroamphetamine and amphetamine) tablets in the 30-mg strength are being sold on the Internet.

May 29, 2012
Sun appoints former Teva CEO as chairman

Generic drug maker Sun Pharmaceutical Industries appointed a new chairman as the company announced big jumps in fourth-quarter and fiscal year 2012 sales and profits.

MUMBAI, India — Generic drug maker Sun Pharmaceutical Industries appointed a new chairman as the company announced big jumps in fourth-quarter and fiscal year 2012 sales and profits.

The drug maker announced the appointment of former Teva Pharmaceutical Industries president and CEO Israel Makov as chairman. Makov, who began working for Teva in 1995, and led it as president and CEO from 2002 to 2007, is widely credited with that company becoming the world's largest generic drug maker and one of the world's largest drug makers overall.

May 17, 2012
FDA approves generic versions of Plavix

The Food and Drug Administration has approved generic versions of one of the country's top-selling drugs made by eight different companies, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved generic versions of one of the country's top-selling drugs made by eight different companies, the agency said Thursday.

May 8, 2012
Reports: Court upholds Abilify patent

A generic version of a schizophrenia drug made by Otsuka Holdings and Bristol-Myers Squibb can't be launched until April 2015, according to published reports.

NEW YORK — A generic version of a schizophrenia drug made by Otsuka Holdings and Bristol-Myers Squibb can't be launched until April 2015, according to published reports.

Bloomberg reported that the U.S. Court of Appeals for the Federal Circuit upheld the validity of patents covering Abilify (aripiprazole) in the two companies' lawsuit against Teva Pharmaceutical Industries and Apotex.

According to IMS Health, Abilify was the fourth top-selling drug in the United States in 2011, with sales of $5.2 billion.

April 6, 2012
Par launches generic version of Provigil

Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

Par announced the launch of a generic version of Provigil (modafinil), used to treat such sleep disorders as narcolepsy and work shift sleep disorder.

April 5, 2012
Teva entitled to exclusivity on Provigil, FDA decides

Teva is the first company to file for a generic version of a drug to treat sleep disorders, the Food and Drug Administration has determined.

JERUSALEM — Teva is the first company to file for a generic version of a drug used to treat sleep disorders, the Food and Drug Administration has determined, though Mylan is contesting the FDA decision.

April 2, 2012
Teva launches generic hypertension drugs

Teva Pharmaceutical Industries has launched generic versions of two blood pressure drugs made by Sanofi, Teva said Monday.

JERUSALEM — Teva Pharmaceutical Industries has launched generic versions of two blood pressure drugs made by Sanofi, Teva said Monday.

Teva announced the launch of irbesartan and irbesartan/hydrochlorothiazide tablets, respectively generic versions of Avapro and Avalide. Avapro has annual sales of $464 million, and Avalide has annual sales of $124 million, according to IMS Health. Both drugs are used to treat high blood pressure, also known as hypertension.