Regulation - North America, Mylan Laboratories

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Watson gets FDA final approval for generic Actos; negative news on Prochieve appeal

29-10-2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) said on Friday that it has launched a generic…

ActosDiabetesGenericsLegalMylan LaboratoriesNorth AmericaProchieveRegulationReproductiveTakeda PharmaceuticalsWatson Pharmaceuticals

Mylan debuts first generic Diovan HCT and Antivert copy in USA

23-09-2012

US generic drugmaker Mylan (Nasdaq: MYL) last Friday received final approval from the US Food and Drug…

AntivertCardio-vascularDiovan HCTGenericsMarkets & MarketingMylan LaboratoriesNeurologicalNorth AmericaNovartisPfizerRegulation

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

Watson debuts generic Nexium in Europe; Mylan launches Amidate copy in USA

08-08-2012

US generics firm Watson Pharmaceuticals (NYSE: WPI) said yesterday that its third-party business Specifar…

AmidateAstraZenecaEuropeGastro-intestinalsGenericsHospiraMarkets & MarketingMylan LaboratoriesNeurologicalNexiumNorth AmericaRegulationWatson 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

US FDA approves generic versions of blood thinner Plavix

18-05-2012

Coinciding with the loss of patent protection on Sanofi (Euronext: SAN) and Bristol-Myers Squibb's (NYSE:…

Cardio-vascularClopidogrelDr Reddy's LaboratoriesGenericsMylan LaboratoriesNorth AmericaPlavixRegulation

Mylan debuts Lescol copy; Impax challenges Gralise patent

16-04-2012

US generic drug major Mylan (Nasdaq: MYL) revealed last Friday that it has begun shipping its generic…

Cardio-vascularDepomedGenericsGraliseImpax LaboratoriesLescolMarkets & MarketingMylan LaboratoriesNeurologicalNorth AmericaNovartisPatentsRegulation

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

FDA approves first generics of Roche osteo drug Boniva

20-03-2012

The US Food and Drug Administration yesterday approved the first generic versions of Boniva (ibandronate)…

Anti-Arthritics/RheumaticsApotexBonivaGenericsMylan LaboratoriesNorth AmericaOrchid HealthcareRegulationRoche

Mylan gets OK for generic Crestor in Canada; Rottapharm deal looks dead

18-03-2012

The Canadian subsidiary of US generic drugmaker Mylan (Nasdaq: MYL) has received approval from Health…

AstraZenecaCardio-vascularCrestorEuropeGenericsMergers & AcquisitionsMylan LaboratoriesNorth AmericaPharmaceuticalRegulationRottapharm

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

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