Regulation - Teva Pharmaceutical Industries

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Arena Pharma in deal with Teva unit for marketing Belviq in Israel

Arena Pharma in deal with Teva unit for marketing Belviq in Israel

21-07-2014

USA-based Arena Pharmaceuticals has entered into an exclusive marketing and supply agreement for its…

AbicArena PharmaceuticalsBelviqLicensingMetabolicsObesityPharmaceuticalRegulationRest of the WorldTeva Pharmaceutical Industries

FDA accepts Teva’s NDA for albuterol MDPI

FDA accepts Teva’s NDA for albuterol MDPI

15-07-2014

Israel-based generic giant Teva Pharmaceuticals Industries says that the US Food and Drug Administration…

albuterolExercise-induced bronchospasmGenericsPulmonologyRegulationRespiratory and PulmonaryTeva Pharmaceutical IndustriesUSA

EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

04-07-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive…

EuropePharmaceuticalRegulationReproductiveSeasoniqueTeva Pharmaceutical IndustriesWomen's Health

Teva files citizen petition with FDA regarding Copaxone complexity

Teva files citizen petition with FDA regarding Copaxone complexity

03-07-2014

Teva Pharmaceutical Industries says it has filed a citizen petition regarding the approvability of purported…

CopaxoneLegalNeurologicalPatentsPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

US FDA approves sNDAs for Imbruvica and Azilect

US FDA approves sNDAs for Imbruvica and Azilect

09-06-2014

USA-based Pharmacyclics says that the US Food and Drug Administration has accepted for filing its supplemental…

AzilectImbruvicaNeurologicalOncologyPharmaceuticalPharmacyclicsRegulationTeva Pharmaceutical IndustriesUSA

Teva and Active Biotech will continue with Nerventra development despite negative CHMP decision

25-05-2014

Teva Pharmaceutical Industries, the world’s largest generic drugs firm, and Swedish partner Active…

Active BiotechEuropeNerventraNeurologicalPharmaceuticalRegulationTeva Pharmaceutical Industries

EU approval for Teva’s DuoResp Spiromax for asthma and COPD

EU approval for Teva’s DuoResp Spiromax for asthma and COPD

30-04-2014

The European Commission has granted marketing authorization for Israel-based Teva Pharmaceutical Industries’…

DuoResp SpiromaxEuropeGenericsRegulationRespiratory and PulmonaryTeva Pharmaceutical Industries

Teva launches first generic Lovaza in USA

Teva launches first generic Lovaza in USA

08-04-2014

Israel-based Teva Pharmaceutical Industries says it has received US Food and Drug Administration approval…

Cardio-vascularGenericsGlaxoSmithKlineLovazaMarkets & MarketingRegulationTeva Pharmaceutical IndustriesUSA

Teva gains approval for generic Evista in the USA

Teva gains approval for generic Evista in the USA

04-03-2014

Israel-based Teva Pharmaceutical Industries says it has received approval from the US Food and Drug Administration…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsNorth AmericaRegulationTeva Pharmaceutical IndustriesUSA

Positive CHMP opinion for Teva’s DuoResp Spiromax for asthma and COPD

22-02-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive…

AstraZenecaDuoResp SpiromaxPharmaceuticalRegulationRespiratory and PulmonarySymbicortTeva Pharmaceutical Industries

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

Takeda to commercialize Teva’s glatiramer acetate for MS in Japan

Takeda to commercialize Teva’s glatiramer acetate for MS in Japan

05-12-2013

Revealing an earlier agreement yesterday, Israel’s Teva Pharmaceutical Industries and Japan’s largest…

Asia-PacificCopaxoneGlatiramer AcetateLicensingNeurologicalPharmaceuticalRegulationTakeda PharmaceuticalsTeva 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

US FDA approves Teva’s generic TOBI

US FDA approves Teva’s generic TOBI

14-10-2013

Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted approval of…

Antibiotics and Infectious diseasesGenericsNovartisRare diseasesRegulationTeva Pharmaceutical IndustriesTobi

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

European Commission OK for Lonquex

09-08-2013

Israel-based Teva Pharmaceutical Industries (NYSE: TEVA|), the world's leading generics drugmaker, says…

AmgenEuropeLonquexOncologyPharmaceuticalRegulationTeva Pharmaceutical Industries

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

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