Regulation - North America, Teva Pharmaceutical Industries

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Teva gains full FDA approval of CML drug Synribo

Teva gains full FDA approval of CML drug Synribo

14-02-2014

Israel-based Teva Pharmaceutical Industries says the US Food and Drug Administration has granted full…

North AmericaOncologyPharmaceuticalRegulationSynriboTeva Pharmaceutical IndustriesUSA

Teva gets FDA approval of three-times-a-week Copaxone

Teva gets FDA approval of three-times-a-week Copaxone

29-01-2014

Israel’s Teva Pharmaceutical Industries says that the US Food and Drug Administration has approved…

CopaxoneNeurologicalNorth AmericaPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

US FDA approves first generic versions of antidepressant drug Cymbalta

US FDA approves first generic versions of antidepressant drug Cymbalta

12-12-2013

The US Food and Drug Administration yesterday approved the first generic versions of drug major Eli Lilly’s…

Aurobindo PharmaCymbaltaDr Reddy's LaboratoriesDuloxetine HclEli LillyGenericsLupinNeurologicalNorth AmericaRegulationSun Pharmaceutical IndustriesTeva Pharmaceutical Industries

Teva gains additional regulatory exclusivity for Treanda

Teva gains additional regulatory exclusivity for Treanda

28-11-2013

Israel-based global generic giant Teva Pharmaceutical Industries has been granted orphan drug exclusivity…

North AmericaOncologyPharmaceuticalRegulationTeva Pharmaceutical IndustriesTreanda

Teva updates on Lonquex and Granix launches

Teva updates on Lonquex and Granix launches

18-11-2013

Israel-based Teva Pharmaceutical Industries announced two significant additions to its global oncology…

balugrastimBiosimilarsEuropeGenericsLonquexMarkets & MarketingNorth AmericaOncologyRegulationTeva Pharmaceutical Industries

FDA approval for Teva's leukemia drug Treanda

18-09-2013

The US Food and Drug Administration has approved Treanda (bendamustine HCI) Injection from Israeli…

North AmericaOncologyPharmaceuticalRegulationTeva Pharmaceutical IndustriesTreanda

US FDA approves first generic Xeloda for colorectal and breast cancers

17-09-2013

The US Food and Drug Administration approved the first generic version of Swiss drug major Roche's (ROG:…

capecitabineGenericsNorth AmericaOncologyRegulationRocheTeva Pharmaceutical IndustriesXeloda

FDA advisory committee backs approval of Sanofi drug for OTC

01-08-2013

The US Food and Drug Administration's Nonprescription Drugs Advisory Committee (NDAC) voted 10 to six,…

Nasacort AQNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySanofiTeva Pharmaceutical Industries

FDA approves Plan B One-Step emergency contraceptive for OTC use by women of child-bearing potential

21-06-2013

The US Food and Drug Administration has approved the use of Plan B One-Step (levonorgestrel), from Israel-headquartered…

North AmericaPharmaceuticalPlan B One-StepRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

FDA approves Raptor's Procysbi for rare genetic condition; and Plan B One-Step

01-05-2013

US drugmaker Raptor Pharmaceuticals (Nasdaq: RPTP) saw its share price rise 7.5% to $7.06 in mid-afternoon…

North AmericaPharmaceuticalPlan B One-StepProcysbiRaptor PharmaceuticalsRare diseasesRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

US FDA approves Lupin's generic version of Teva's Seasonique and Taro's Topicort

15-04-2013

Indian drugmaker Lupin (BSE: 500257) saw its shares gain 2.3% to 659.65 rupees by close of trading on…

DayseeDermatologicalsGenericsLupinMarkets & MarketingNorth AmericaPharmaceuticalRegulationReproductiveSeasoniqueTaro PharmaceuticalsTeva Pharmaceutical IndustriesTopicort

US FDA approves Teva's oral contraceptive Quartette

02-04-2013

There was good news for Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) when the US Food…

North AmericaPharmaceuticalQuartetteRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

Actavis settles with Mallinckrodt over Exalgo 32mg; Teva gains FDA OK for Adderall XR

14-02-2013

US generics drug major Actavis (NYSE: ACT) has reached a settlement with Mallinckrodt (NYSE: MKG) on…

ActavisAdderall XRExalgoGenericsMallinckrodtNeurologicalNorth AmericaPatentsRegulationShireTeva Pharmaceutical Industries

FDA approves Teva's Synribo for CML; Novartis plans for Tasigna switch

29-10-2012

The US Food and Drug Administration on Friday approved Israel-headquartered Teva Pharmaceutical Industries'…

GleevecNorth AmericaNovartisOncologyPatentsPharmaceuticalRegulationResearchSynriboTasignaTeva Pharmaceutical Industries

Teva/Impax generic Wellbutrin XL 300mg pulled from US market on non-bioequivalence grounds

04-10-2012

Following a review of new data, the US Food and Drug Administration says these indicate that Budeprion…

Bupropion HclGenericsGlaxoSmithKlineImpax LaboratoriesNeurologicalNorth AmericaRegulationTeva Pharmaceutical IndustriesWellbutrin XL

FDA approves pediatric Afinitor from Novartis and Teva's tbo-filgrastim

30-08-2012

The US Food and Drug Administration yesterday approved Swiss drug major Novartis' (NOVN: VX) Afinitor…

AfinitorBiotechnologyGenericsNorth AmericaNovartisOncologyPharmaceuticalRegulationSicor Biotechtbo-filgrastimTeva Pharmaceutical Industries

Ranbaxy debuts authorized Actos generic in USA, followed by Teva and Mylan

20-08-2012

The US subsidiary of Ranbaxy Laboratories (AB: BO), India's largest drugmaker, has launched authorized…

ActoplusMetActosDiabetesGenericsMarkets & MarketingMylan LaboratoriesNorth AmericaRanbaxy LaboratoriesRegulationTakeda PharmaceuticalsTeva Pharmaceutical Industries

US FDA accepts Teva's Quartette NDA

13-08-2012

The US Food and Drug Administration has accepted for filing the New Drug Application for Quartette (levonorgestrel/ethinyl…

North AmericaPharmaceuticalQuartetteRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

FDA approves first generic copies of Merck & Co's Singulair; and Pulmicort Respules

06-08-2012

The US Food and Drug Administration on Friday approved the first generic versions of Singulair (montelukast…

AstraZenecaGenericsMerck & CoMylan LaboratoriesNorth AmericaPulmicort RespulesRegulationRespiratory and PulmonarySandozSingulairTeva Pharmaceutical IndustriesWatson Pharmaceuticals

USA FDA approves ANDAs for Plan B One-Step and Trandate

16-07-2012

Watson Pharmaceuticals (NYSE: WPI) says its subsidiary Watson Laboratories approval from the US Food…

Cardio-vascularGenericsNorth AmericaPar PharmaceuticalsPlan B One-StepRegulationReproductiveTeva Pharmaceutical IndustriesTrandateWatson Pharmaceuticals

FDA delays once-a-day Prezista approval; finds counterfeit of Teva's Adderall

30-05-2012

US health care giant Johnson & Johnson's (NYSE: JNJ) Janssen Therapeutics division has received a complete…

AdderallAnti-viralsGenericsJanssenJohnson & JohnsonMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalPrezistaRegulationTeva Pharmaceutical Industries

FDA decides Teva is sole first-to-file on Provigil; Mylan argues ruling

09-04-2012

Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA) said on April 5 that the US Food and Drug…

CephalonGenericsLegalModafinilMylan LaboratoriesNeurologicalNorth AmericaPar PharmaceuticalProvigilRegulationTeva Pharmaceutical Industries

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