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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

Mylan cleared to sell generic Wellbutrin XL in USA

26-08-2013

There was good news last week for US specialty and generics company Mylan (Nasdaq: MYL), when the US…

GenericsGlaxoSmithKlineMylan LaboratoriesNeurologicalNorth AmericaRegulationWellbutrin XL

Sales of antiretroviral agents for HIV will decline slightly over next decade

18-12-2012

Major-market sales of antiretroviral (ARV) agents for HIV will decline slightly over the next decade,…

Anti-viralsBiotechnologydolutegravirGenericsGlaxoSmithKlineGlobalMarkets & MarketingPharmaceuticalRegulationViiV Healthcare

India's Elder Pharma to enter EU markets; comment on GSK Indian OTC moves

26-11-2012

Indian drugmaker Elder Pharmaceuticals says it is ready to enter the European Union market following…

Asia-PacificdiosminElder PharmaceuticalsEuropeGenericsGlaxoSmithKlineMarkets & MarketingMergers & AcquisitionsPharmaceuticalRegulation

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

GlaxoSmithKline pulls sNDA for Tykerb plus Herceptin; Watson/Actavis update

13-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed yesterday that it has withdrawn a supplemental New…

ActavisGenericsGlaxoSmithKlineHerceptinMergers & AcquisitionsNorth AmericaOncologyPharmaceuticalRegulationRocheTykerbWatson Pharmaceuticals

Mylan debuts generic Epivir in Europe; gets Canadian OK for Tracleer copy

07-06-2012

US generic drugs major Mylan (Nasdaq: MYL) says that its UK and Italy-based subsidiaries have launched…

ActelionAnti-viralsEpivirEuropeGenericsGlaxoSmithKlineMarkets & MarketingMylan LaboratoriesNorth AmericaRegulationRespiratory and PulmonaryTracleer

News briefs: Genmab/GSK, Gilead and Mylan

24-05-2012

Denmark's Genmab (OMX: GEN) yesterday received a milestone payment of 20 million Danish kroner ($3.4…

Anti-viralsBiotechnologycobicistatFinancialGenericsGenmabGilead SciencesGlaxoSmithKlineMylan LaboratoriesOncologyRegulationViramune

Mylan gets tentative FDA approval for generic Epzicom

23-02-2012

US generics major Mylan (Nasdaq: MYL) says that its subsidiary Mylan Laboratories has received tentative…

Anti-viralsEpzicomGenericsGlaxoSmithKlineMylan LaboratoriesNorth AmericaPfizerRegulationViiV Healthcare

US ANDAs filed for generic Beyaz, Isentress and Epivir

12-01-2012

The US Food and Drug Administration says that Abbreviated New Drug Applications have been received by…

Anti-viralsBayerBeyazEpivirGenericsGlaxoSmithKlineIsentressMerck & CoPharmaceuticalRegulationReproductive

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