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US FDA approval for AstraZeneca’s Epanova

US FDA approval for AstraZeneca’s Epanova

06-05-2014

There was good news today for Anglo-Swedish drug major AstraZeneca, as the US Food and Drug Administration…

AstraZenecaCardio-vascularEpanovaLovazaPharmaceuticalRegulationUSAVascepa

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

Amarin calls on FDA to extend Vascepa exclusivity by five years

28-02-2014

US biotech firm Amarin has filed with a federal court requesting it to order the US Food and Drug Administration…

AmarinBiotechnologyCardio-vascularGlaxoSmithKlineLegalLovazaNorth AmericaUSAVascepa

US Appeals Court reverses 2012 decision on Lovaza, clearing way for generics

13-09-2013

Reversing a district court decision last year (The Pharma Letter May 30, 2012), the US Court of Appeals…

AmarinCardio-vascularGenericsGlaxoSmithKlineLegalLovazaNorth AmericaPar PharmaceuticalsPatentsPharmaceuticalTeva Pharmaceutical IndustriesVascepa

US FDA clears Amarin's Vascepa, a competitor for Lovaza

30-07-2012

The US Food and Drug Administration has approved biotech firm Amarin's (Nasdaq: AMRN) Vascepa (icosapent…

AmarinBiotechnologyCardio-vascularGlaxoSmithKlineLovazaMergers & AcquisitionsNorth AmericaRegulationVascepa

US court rules in favor of Pronova/GlaxoSmithKline in Lovaza patent dispute

30-05-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) which has the marketing rights for Lovaza (omega-3-acid ethyl…

Cardio-vascularGlaxoSmithKlineLegalLovazaNorth AmericaPatentsPharmaceuticalPronova BioPharmaTeva Pharmaceutical Industries

Amarin will apply for approval of cholesterol drug candidate AMR101 earlier on strong Ph III results

30-11-2010

US/Irish biopharmaceutical firm Amarin (Nasdaq: AMRN), yesterday reported positive, statistically significant…

AmarinCardio-vascularGlaxoSmithKlineLovazaNorth AmericaPharmaceuticalRegulationResearch

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