Pharmaceutical - Pharmaceutical, North America, Reproductive

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US FDA approval for Warner Chilcott's new oral contraceptive

26-07-2013

The US Food and Drug Administration have approved the use of a new oral contraceptive from Ireland-based…

ActavisLo Minastrin FeNorth AmericaPharmaceuticalRegulationReproductiveWarner Chilcott

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

US FDA grants priority review for Janssen's simeprevir, accepts Biogen Idec's Eloctate and Actavis' progestin-only patch filing

13-05-2013

The US Food and Drug Administration has granted Priority Review to the New Drug Application for simeprevir…

ActavisAnti-viralsBiogen IdecBiotechnologyEloctateJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationReproductivesimeprevirTMC435

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

Patent briefs: Yaz patent invalid; FDA bars generic OxyContin; Appeals court backs GSK over Arzerra

17-04-2013

US generics major Actavis (NYSE: ACT, previously trading as Watson) said yesterday (April 16) that it…

ActavisArzerraBayerGenericsGenmabGlaxoSmithKlineNeurologicalNorth AmericaOncologyOxyContinPatentsPharmaceuticalPurdue PharmaReproductiveYaz

US FDA approves Lupin's generic version of Teva's Seasonique and Taro's Topicort

15-04-2013

Indian drugmaker Lupin (BSE: 500257) saw its shares gain 2.3% to 659.65 rupees by close of trading on…

DayseeDermatologicalsGenericsLupinMarkets & MarketingNorth AmericaPharmaceuticalRegulationReproductiveSeasoniqueTaro PharmaceuticalsTeva Pharmaceutical IndustriesTopicort

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

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

News briefs: Italy lifts hold on Novartis vaccines; files for QVA149 in Japan; Mylan patent settlement

11-11-2012

The Italian Medicines Agency (AIFA) said last Friday that the temporary halt on the use of Swiss drug…

AgrippalAsia-PacificEuropeFluadGenericsJanssenJohnson & JohnsonMylan LaboratoriesNorth AmericaNovartisOrtho Tri-Cyclen LoPatentsPharmaceuticalQVA149RegulationReproductiveRespiratory and PulmonaryVaccines

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

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

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

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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