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US FDA clears new ED drug Stendra

30-04-2012

The US Food and Drug Administration late Friday gave its approval for drug developer Vivus (Nasdaq: VVUS)…

avanafilMen's HealthNorth AmericaPharmaceuticalRegulationReproductiveStendraVivus

Bayer's Xarelto reimbursement backed in Canada; EMA concludes Yvidually arbitration

24-04-2012

The Canadian Agency for Drugs and Technologies in Health (CADTH) through the Common Drug Review (CDR),…

BayerCardio-vascularEuropeNorth AmericaPharmaceuticalPricingRegulationReproductiveXareltoYvidually

Bayer updates drospirenone-containing COCs labels to reflect VTE risk

11-04-2012

Following a further review of the products by the US Food and Drug Administration , Bayer HealthCare…

BayerBeyazdrospirenoneNorth AmericaPharmaceuticalRegulationReproductiveWomen's HealthYasminYaz

Columbia Labs hands over NDA to Watson

13-02-2012

Columbia Laboratories (Nasdaq: CBRX) has transferred the New Drug Application for progesterone vaginal…

Columbia LaboratoriesCrinoneLicensingNorth AmericaPharmaceuticalRegulationReproductiveWatson PharmaceuticalsWomen's Health

Watson confirms patent challenge to Bayer’s Beyaz

13-02-2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) on Friday confirmed that its subsidiary, Watson…

BayerBeyazGenericsNorth AmericaPatentsRegulationReproductiveWatson Pharmaceuticals

FDA Advisory thumbs down for Columbia and Watson product

23-01-2012

US drugmakers Columbia Laboratories (Nasdaq: CBRX) and Watson Pharmaceuticals (NYSE: WPI) confirmed on…

Columbia LaboratoriesCrinoneNorth AmericaPharmaceuticalRegulationReproductiveWatson PharmaceuticalsWomen's Health

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

FDA panel mixed on Ortho Evra

12-12-2011

The majority of members of the US Food and Drug Administration’s Reproductive Health Drugs Advisory…

Johnson & JohnsonNorth AmericaOrtho EvraPharmaceuticalRegulationReproductiveWomen's Health

Mixed views on drospirenone OCs

09-12-2011

The majority of members of the US Food and Drug Administration’s Reproductive Health Drugs Advisory…

BayerDrospirenone and EstradiolNorth AmericaPharmaceuticalRegulationReproductiveWomen's HealthYasminYaz

FDA approves Lilly’s Cialis to treat benign prostatic hyperplasia

07-10-2011

The US Food and Drug Administration yesterday approved drug major Eli Lilly’s (NYSE: LLY) Cialis…

CialisEli LillyNorth AmericaPharmaceuticalRegulationReproductive

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