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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

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

Actavis wins generic Pulmicort Respules case; challenges AbbVie patent

02-04-2013

US generic drugs maker Actavis (NYSE: ACT) has confirmed that the US District Court for the District…

AbbVieActavisAndroGelAstraZenecaGenericsMarkets & MarketingMen's HealthNorth AmericaPatentsPulmicort RespulesRegulationRespiratory and Pulmonary

Regulatory briefs from GSK/Theravance, Allergan and Mylan

19-12-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX0 have submitted a…

AllerganAnoro ElliptaBotoxEuropeGenericsGenito-urinaryGlaxoSmithKlineMylan LaboratoriesNorth AmericaPharmaceuticalQualaquinRegulationRelvarRespiratory and PulmonaryTheravanceTropical diseases

Watson gains FDA approval for generic Revatio

12-11-2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) has received approval from the US Food and Drug…

GenericsNorth AmericaPfizerRegulationRespiratory and PulmonaryRevatioWatson Pharmaceuticals

FDA approves first generic copies of Merck & Co's Singulair; and Pulmicort Respules

06-08-2012

The US Food and Drug Administration on Friday approved the first generic versions of Singulair (montelukast…

AstraZenecaGenericsMerck & CoMylan LaboratoriesNorth AmericaPulmicort RespulesRegulationRespiratory and PulmonarySandozSingulairTeva Pharmaceutical IndustriesWatson Pharmaceuticals

Watson confirms patent challenges for Xopenox HFA and Epiduo Gel

31-07-2012

US generics drugmaker Watson Pharmaceuticals NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories…

Dainippon Sumitomo PharmaDermatologicalsEpiduo GelGaldermaGenericsLegalNorth AmericaRegulationRespiratory and PulmonarySunovionWatson PharmaceuticalsXopenox

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

Sandoz challenges United Thera’s Remodulin patents

06-02-2012

US drugmaker United Therapeutics (Nasdaq: UTHR) says that it has received a Paragraph IV Certification…

GenericsNorth AmericaNovartisPatentsPharmaceuticalRegulationRemodulinRespiratory and PulmonarySandozUnited Therapeutics

Perrigo confirms ANDA filing for generic Astepro nasal spray

24-01-2012

US generic drugmaker Perrigo (Nasdaq: PRGO;TASE) says that it has filed an Abbreviated New Drug Application…

AsteproAzelastine HydrochlorideGenericsImpax LaboratoriesLegalMedaNorth AmericaPatentsPerrigoRegulationRespiratory and Pulmonary

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