Regulation - Boehringer Ingelheim, USA

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Tentative FDA approval for Lilly and Boehringer Ingelheim's Basaglar

Tentative FDA approval for Lilly and Boehringer Ingelheim's Basaglar

19-08-2014

The US Food and Drug Administration yesterday granted tentative approval for Basaglar (insulin glargine…

AbasriaBasaglarBiosimilarsBoehringer IngelheimDiabetesEli LillyInsulin Glargine [rDNA origin] InjectionLantusPharmaceuticalRegulationUSA

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

15-08-2014

There was good news late yesterday for German family-owned pharma major Boehringer Ingelheim, when an…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivatiotropiumUS Food and Drug AdministrationUSA

US FDA approves Jardiance for adults with type 2 diabetes

US FDA approves Jardiance for adults with type 2 diabetes

02-08-2014

The US Food and Drug Administration on Friday approved Jardiance (empagliflozin) tablets as an adjunct…

Boehringer IngelheimDiabetesEli LillyEuropeGermanyJardiancePharmaceuticalRegulationUSA

FDA approves Boehringer’s Striverdi Respimat for COPD

FDA approves Boehringer’s Striverdi Respimat for COPD

01-08-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimPharmaceuticalPulmonologyRegulationRespiratory and PulmonaryStriverdi RespimatUSA

US breakthrough designation in IPF for Boehringer’s nintedanib

US breakthrough designation in IPF for Boehringer’s nintedanib

17-07-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation for German family-owned…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

Mylan launches generic Micardis in USA

Mylan launches generic Micardis in USA

08-07-2014

US generic drugmaker Mylan has launched Telmisartan Tablets USP, 20mg, 40mg and 80mg, the generic version…

Boehringer IngelheimCardio-vascularGenericsMarkets & MarketingMicardisMylanRegulationTelmisartanUSA

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

02-07-2014

The US subsidiary of German family-owned drug major Boehringer Ingelheim says that the New Drug Application…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

26-06-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to idarucizumab, an…

Boehringer IngelheimCardio-vascularidarucizumabPharmaceuticalPradaxaRegulationResearchUSA

Boehringer and Lilly re-file empagliflozin NDA with FDA

Boehringer and Lilly re-file empagliflozin NDA with FDA

19-06-2014

The US subsidiary of German family-owned drugmaker Boehringer Ingelheim and pharma major Eli Lilly have…

Boehringer IngelheimDiabetesEli LillyempagliflozinPharmaceuticalRegulationUSA

Boehringer resolves FDA manufacturing facility concerns

Boehringer resolves FDA manufacturing facility concerns

03-06-2014

German family-owned pharma major Boehringer Ingelheim said today that it has been notified by a letter…

Boehringer IngelheimFood and Drug AdministrationGermanyPharmaceuticalPharmaceutical sciencesProductionRegulationResearchUSA

FDA finds favorable risk:benefit balance for Boehringer’s Pradaxa

18-05-2014

As part of its ongoing review, the US Food and Drug Administration last week released latest findings…

Boehringer IngelheimCardio-vascularPharmaceuticalPradaxaRegulationUSA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

14-04-2014

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational…

Boehringer IngelheimDiabetesEli LillyempagliflozinJardiancelinagliptinNorth AmericaPharmaceuticalRegulationTradjentaUSA

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

07-04-2014

The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s…

Boehringer IngelheimCardio-vascularNorth AmericaPharmaceuticalPradaxaRegulationUSA

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

05-03-2014

There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer…

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

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