Premenstrual Dysphoric Disorder
📧 Sign up to get email alerts when something new happens for Premenstrual Dysphoric Disorder.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2016-12-27FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)
FDA granted a supplemental approval for a generic fluoxetine product from Aurobindo Pharma Limited under an ANDA.
-
FDA approval · 2016-12-27FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)
The FDA approved a supplemental application for fluoxetine (generic) from Saptalis Pharmaceuticals, LLC, for continued marketing under the a…
-
FDA approval · 2016-12-23FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for sertraline hydrochloride (generic) manufactured by Mylan Pharmaceuticals Inc.; this represen…
-
FDA approval · 2016-10-21FDA Approved: FLUOXETINE — Original Application (Torrent Pharmaceuticals Limited)
The FDA approved Torrent Pharmaceuticals Limited's original application for fluoxetine, authorizing the marketing of a generic fluoxetine pr…
-
CLINICAL_TRIALS trial_result · 2016-10-19Clinical Trial Update: Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder [Phase 4]
Phase 4 trial evaluating the effectiveness of sertraline for treating Premenstrual Dysphoric Disorder in women; results were posted in 2016.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS trial_result · 2016-08-24Clinical Trial Update: Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD) [Phase 4]
A Phase 4 clinical trial evaluating continuous oral contraceptive treatment for Premenstrual Dysphoric Disorder has completed and results ha…
-
FDA approval · 2016-08-19FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Endo USA, Inc.)
FDA approves Endo USA, Inc.'s fluoxetine hydrochloride as an Original Application, providing a generic version of fluoxetine hydrochloride.
-
FDA approval · 2016-08-01FDA Approved: PROZAC — Supplemental Application (Dista Products Company)
FDA approves a supplemental application for PROZAC (fluoxetine hydrochloride) submitted by Dista Products Company.
-
FDA approval · 2016-03-14FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for sertraline hydrochloride from Aurobindo Pharma Limited, enabling the commercialization of a gene…
-
FDA approval · 2016-01-12FDA Approved: FLUOXETINE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for fluoxetine from Alembic Pharmaceuticals Limited.
-
CLINICAL_TRIALS trial_result · 2016-01-12Clinical Trial Update: Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder [Phase 1, Phase 2]
This clinical trial update reports completion of Phase 1 and Phase 2 evaluation of an antidepressant treatment for Premenstrual Syndrome and…
-
FDA label_change · 2016-01-10FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc. to update the product labeling.
-
FDA approval · 2015-12-23FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for sertraline hydrochloride (Lupin Pharmaceuticals, Inc.), a generic product under an ANDA.
-
CLINICAL_TRIALS research · 2015-12-03Clinical Trial Update: Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder [Phase 3]
This document provides an update on a Phase 3 clinical trial evaluating intranasal PH80 spray for acute management of Premenstrual Dysphoric…
-
FDA approval · 2015-11-24FDA Approved: PROZAC — Supplemental Application (Dista Products Company)
FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company.
-
FDA approval · 2015-06-09FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for sertraline hydrochloride (generic) from Quallent Pharmaceuticals Health LLC under ANDA077397.
-
CLINICAL_TRIALS research · 2015-05-20Clinical Trial Update: Deep Transcranial Magnetic Stimulation (dTMS) for the Treatment of Premenstrual Dysphoric Disorder (PMDD) [NA]
An ongoing clinical trial is evaluating deep transcranial magnetic stimulation as a treatment for Premenstrual Dysphoric Disorder; no result…
-
FDA approval · 2015-03-16FDA Approved: FLUOXETINE — Original Application (Vensun Pharmaceuticals, Inc.)
The FDA approved Vensun Pharmaceuticals' original (ANDA) application for fluoxetine hydrochloride, establishing a generic fluoxetine product…
-
CLINICAL_TRIALS trial_result · 2015-01-21Clinical Trial Update: A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD) [Phase 1, Phase 2]
This clinical trial update summarizes the completion of a Phase I/II study evaluating UC1010 for Premenstrual Dysphoric Disorder (PMDD) cond…
-
FDA approval · 2015-01-12FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)
FDA approved a supplemental application for a generic fluoxetine product (ANDA 076458) from Chartwell Governmental & Specialty RX, LLC. This…
-
FDA approval · 2014-12-01FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for paroxetine submitted by Padagis US LLC, adding or updating labeling under the existing NDA.
-
FDA approval · 2014-11-26FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for PAROXETINE (paroxetine hydrochloride) from Zydus Lifesciences Limited, enabling the marketing of…
-
FDA approval · 2014-11-07FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Accord Healthcare, Inc.)
FDA approves Accord Healthcare, Inc.'s generic sertraline hydrochloride under an Original Application (ANDA 202825).
-
FDA approval · 2014-10-27FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride, a generic version of sertraline. This action …
-
FDA approval · 2014-10-10FDA Approved: PROZAC — Supplemental Application (Dista Products Company)
FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company.