Regulation - Reproductive, Women's Health

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EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

EMA/CHMP positive opinion for Teva’s Seasonique contraceptive

04-07-2014

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive…

EuropePharmaceuticalRegulationReproductiveSeasoniqueTeva Pharmaceutical IndustriesWomen's Health

Benefits of combined hormonal contraceptives continue to outweigh risks, says EMA/CHMP

Benefits of combined hormonal contraceptives continue to outweigh risks, says EMA/CHMP

23-11-2013

The European Medicines Agency has now completed its review of combined hormonal contraceptives (CHCs),…

EuropePharmaceuticalRegulationReproductiveWomen's Health

FDA approves Plan B One-Step emergency contraceptive for OTC use by women of child-bearing potential

21-06-2013

The US Food and Drug Administration has approved the use of Plan B One-Step (levonorgestrel), from Israel-headquartered…

North AmericaPharmaceuticalPlan B One-StepRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

Actavis confirms patent challenge on Bayer's Safyral

06-06-2013

USA-based generics major Actavis (NYSE: ACT) yesterday (June 5) confirmed that it has filed an Abbreviated…

ActavisBayerGenericsPatentsRegulationReproductiveSafyralWomen's Health

FDA approves Raptor's Procysbi for rare genetic condition; and Plan B One-Step

01-05-2013

US drugmaker Raptor Pharmaceuticals (Nasdaq: RPTP) saw its share price rise 7.5% to $7.06 in mid-afternoon…

North AmericaPharmaceuticalPlan B One-StepProcysbiRaptor PharmaceuticalsRare diseasesRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

US FDA approves Teva's oral contraceptive Quartette

02-04-2013

There was good news for Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) when the US Food…

North AmericaPharmaceuticalQuartetteRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

EMA to review third- and fourth-generation combined OCs; France investigates Diane-35

29-01-2013

The European Medicines Agency has been asked by France to review third- and fourth-generation combined…

BayerDermatologicalsDiane-35EuropePharmaceuticalRegulationReproductiveWomen's Health

Bayer's long-term contraceptive IUD Skyla gets US FDA approval

11-01-2013

The US Food and Drug Administration has approved German drug major Bayer's (BAYN: DE) Skyla (levonorgestrel-releasing…

BayerNorth AmericaPharmaceuticalRegulationReproductiveSkylaWomen's Health

Bayer's contraceptive Flexyess gets EC backing

10-10-2012

Bayer HealthCare, the drugs unit of Germany's Bayer AG (BAYN: DE), said yesterday that it has received…

BayerdrospirenoneethinylestradiolEuropeFlexyessPharmaceuticalRegulationReproductiveWomen's Health

Bayer files for EU approval of low-dose contraceptive patch

21-09-2012

German drug major Bayer (BAYN: DE) yesterday submitted an application for marketing authorization in…

BayerethinylestradiolEuropegestodenePharmaceuticalRegulationReproductiveWomen's Health

US FDA accepts Teva's Quartette NDA

13-08-2012

The US Food and Drug Administration has accepted for filing the New Drug Application for Quartette (levonorgestrel/ethinyl…

North AmericaPharmaceuticalQuartetteRegulationReproductiveTeva Pharmaceutical IndustriesWomen's Health

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

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

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

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