Premenstrual Dysphoric Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-01-25FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (NorthStar Rx LLC)
FDA approved an original generic application for fluoxetine hydrochloride from NorthStar Rx LLC. Fluoxetine hydrochloride is used to treat m…
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FDA approval · 2019-01-10FDA Approved: FLUOXETINE — Original Application (ScieGen Pharmaceuticals, Inc.)
FDA approved ScieGen Pharmaceuticals' original abbreviated new drug application for fluoxetine hydrochloride (generic fluoxetine), authorizi…
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FDA approval · 2018-11-21FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Taro Pharmaceuticals U.S.A., Inc.)
FDA granted approval for the original application of a generic fluoxetine hydrochloride product.
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FDA approval · 2018-05-08FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)
The FDA approves Accord Healthcare, Inc.'s supplemental application for sertraline hydrochloride (sertraline HCl).
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CLINICAL_TRIALS research · 2018-03-16Clinical Trial Update: Neurofeedback Treatment of Affective Instability in Premenstrual Dysphoric Disorder(PMDD) [NA]
Clinical trial update on neurofeedback treatment for affective instability in Premenstrual Dysphoric Disorder (PMDD), with Depression listed…
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FDA approval · 2017-12-08FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for sertraline hydrochloride submitted by Mylan Pharmaceuticals, likely affecting the product la…
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FDA approval · 2017-11-20FDA Approved: FLUOXETINE — Original Application (NIVAGEN PHARMACEUTICALS, INC.)
FDA approved NIVAGEN Pharmaceuticals' original application for fluoxetine hydrochloride, granting marketing approval for a generic version o…
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FDA approval · 2017-11-16FDA Approved: FLUOXETINE — Original Application (Endo USA, Inc.)
FDA approves Endo USA, Inc.'s original application for a generic fluoxetine product.
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FDA approval · 2017-08-03FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Sertraline Hydrochloride submitted by Rising Pharma Holdings, Inc.
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CLINICAL_TRIALS trial_result · 2017-07-17Clinical Trial Update: The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder [Phase 4]
Phase 4 clinical trial update evaluating the role of GABA and neurosteroids in Premenstrual Dysphoric Disorder and Premenstrual Syndrome, wi…
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CLINICAL_TRIALS trial_result · 2017-06-27Clinical Trial Update: Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study [Phase 2, Phase 3]
This clinical trial update reports results from a pilot study investigating emotional processing and oxytocin mechanisms in Premenstrual Dys…
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FDA approval · 2017-06-15FDA Approved: ZOLOFT — Supplemental Application (ROERIG)
FDA approved a supplemental application for ZOLOFT (sertraline hydrochloride) submitted by ROERIG, indicating an approved modification to th…
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FDA approval · 2017-04-28FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)
The FDA has approved a supplemental application for paroxetine filed by Padagis US LLC. This notice indicates FDA approval of an amendment t…
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FDA approval · 2017-04-05FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)
FDA approves Alembic Pharmaceuticals Limited's original application for fluoxetine hydrochloride (fluoxetine) as a generic drug.
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CLINICAL_TRIALS trial_result · 2017-02-20Clinical Trial Update: The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels
A completed clinical trial update assessing whether phases of the menstrual cycle influence blood levels of lithium and sertraline in indivi…
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FDA approval · 2017-01-04FDA Approved: PROZAC — Supplemental Application (Dista Products Company)
FDA approved a supplemental application for PROZAC (fluoxetine hydrochloride) submitted by Dista Products Company.
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FDA approval · 2017-01-04FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for fluoxetine from Dr. Reddy's Laboratories Limited.
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FDA approval · 2017-01-04FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for a generic fluoxetine hydrochloride product manufactured by Lannett Company, Inc.
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FDA approval · 2017-01-04FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approves a supplemental application from Aurobindo Pharma Limited to market a generic fluoxetine product.
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FDA approval · 2017-01-04FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)
FDA approved a supplemental application for fluoxetine submitted by Saptalis Pharmaceuticals, LLC.
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FDA approval · 2017-01-04FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
The FDA approved a supplemental application for a generic Fluoxetine hydrochloride product from PAI Holdings dba PAI Pharma under ANDA 07601…
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CLINICAL_TRIALS trial_result · 2017-01-02Clinical Trial Update: Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives [Phase 2]
Phase 2 trial comparing continuous versus interrupted oral contraceptives for menstrually related disorders was terminated. Results were pos…
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FDA label_change · 2016-12-28FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for fluoxetine from Dr. Reddy's Laboratories Limited, indicating a labeling-related update to the ge…
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FDA approval · 2016-12-27FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for fluoxetine hydrochloride from Lannett Company, Inc., resulting in approval of their generic fluo…
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FDA approval · 2016-12-27FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental application for fluoxetine hydrochloride from PAI Holdings, LLC dba PAI Pharma.