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 · 2021-09-20FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for fluoxetine hydrochloride, enabling marketing of a generic fluoxetine produc…
-
FDA approval · 2021-09-01FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for fluoxetine hydrochloride from Dr. Reddy's Laboratories Limited (ANDA 078572), updating regulator…
-
FDA approval · 2021-08-31FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)
FDA approved a supplemental application for fluoxetine from Saptalis Pharmaceuticals, confirming the availability of a generic fluoxetine pr…
-
FDA approval · 2021-08-27FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental application for a fluoxetine hydrochloride generic product from PAI Holdings (PAI Pharma). This action approves …
-
FDA approval · 2021-08-25FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
The FDA approved a supplemental application for Fluoxetine from Dr. Reddy's Laboratories Limited.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2021-05-03FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (XLCare Pharmaceuticals, Inc.)
FDA approved the original application for sertraline hydrochloride generic by XLCare Pharmaceuticals, enabling a generic version to be marke…
-
FDA approval · 2021-04-19FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc., updating the generic's labeling under the AN…
-
FDA approval · 2021-02-06FDA Approved: PAXIL — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for Paxil (paroxetine hydrochloride) submitted by Apotex Corp.
-
FDA approval · 2021-01-21FDA Approved: FLUOXETINE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for fluoxetine submitted by Alembic Pharmaceuticals Limited.
-
FDA approval · 2020-12-23FDA Approved: FLUOXETINE — Supplemental Application (Cadila Pharmaceuticals Limited)
FDA approved a supplemental application for Fluoxetine from Cadila Pharmaceuticals Limited, enabling the marketing of this generic fluoxetin…
-
CLINICAL_TRIALS trial_result · 2020-10-28Clinical Trial Update: A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD) [Phase 2]
Phase 2 trial update of Sepranolone (UC1010) for efficacy and safety in Premenstrual Dysphoric Disorder has completed.
-
CLINICAL_TRIALS trial_result · 2020-10-09Clinical Trial Update: Targeting Inter-Hemispheric Alpha Coherence With tACS To Treat PMDD [NA]
A terminated clinical trial investigating transcranial alternating current stimulation (tACS) to target inter-hemispheric alpha coherence fo…
-
FDA approval · 2020-07-21FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for Paroxetine hydrochloride from Apotex Corp., enabling continued marketing of a generic product.
-
FDA approval · 2020-06-10FDA Approved: FLUOXETINE — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's generic fluoxetine through an Original Application (ANDA).
-
FDA approval · 2020-04-28FDA Approved: PROZAC — Supplemental Application (Dista Products Company)
The FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company.
-
FDA approval · 2020-04-08FDA Approved: FLUOXETINE — Original Application (Aurobindo Pharma Limited)
FDA approved a generic fluoxetine product from Aurobindo Pharma Limited under an Original Application (ANDA 213286). Fluoxetine is an SSRI i…
-
FDA approval · 2020-02-21FDA Approved: SERTRALINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application for sertraline from Heritage Pharmaceuticals (d/b/a Avet), signaling approval of a change or additio…
-
FDA approval · 2020-02-21FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride (generic sertraline).
-
FDA approval · 2020-02-21FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for an additional generic version of sertraline hydrochloride, expanding the availability of this an…
-
CLINICAL_TRIALS withdrawal · 2020-01-02Clinical Trial Update: EnBrace HR for PMS With Prominent Mood Symptoms or Menstrual Related Mood Disorders [Phase 4]
Phase 4 trial for EnBrace HR in premenstrual syndrome and mood-related conditions was withdrawn.
-
FDA approval · 2019-09-11FDA Approved: PAROXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)
FDA supplemental approval granted for Apotex Corp's paroxetine hydrochloride product, approving a generic formulation under NDA 020936.
-
FDA approval · 2019-05-23FDA Approved: FLUOXETINE — Original Application (Cadila Pharmaceuticals Limited)
Cadila Pharmaceuticals Limited received FDA approval for an original application of fluoxetine (generic).
-
FDA approval · 2019-04-15FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approves Lupin's original (generic) application for fluoxetine hydrochloride.
-
FDA approval · 2019-03-20FDA Approved: FLUOXETINE — Original Application (ScieGen Pharmaceuticals, Inc)
FDA approved ScieGen Pharmaceuticals' original application for fluoxetine, authorizing the marketing of a generic fluoxetine product. Fluoxe…
-
FDA approval · 2019-01-31FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for sertraline hydrochloride from Rising Pharma Holdings, expanding the availability of a generi…