Premenstrual Dysphoric Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2008-07-16FDA Approved: SERTRALINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approves a supplemental abbreviated new drug application (ANDA) for sertraline from Heritage Pharmaceuticals d/b/a Avet Pharmaceuticals …
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FDA approval · 2008-07-02FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for sertraline hydrochloride (generic sertraline), authorizing the a…
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FDA approval · 2008-06-25FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for sertraline hydrochloride manufactured by Aurobindo Pharma Limited.
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FDA approval · 2008-05-29FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic fluoxetine hydrochloride product from Lannett Company, Inc. under anANDA, confirming r…
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FDA approval · 2008-05-20FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for paroxetine hydrochloride/paroxetine from Zydus Lifesciences Limited, authorizing a generic parox…
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FDA approval · 2008-04-17FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for fluoxetine by Teva Pharmaceuticals USA, Inc. The approval updates the product labeling and/o…
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FDA approval · 2008-03-21FDA 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 · 2008-03-13FDA Approved: PAROXETINE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved a generic paroxetine product (paroxetine hydrochloride hemihydrate) from Mylan Pharmaceuticals Inc. under an original ANDA.
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FDA approval · 2008-03-06FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for sertraline hydrochloride from Mylan Pharmaceuticals Inc., indicating approval of a supplemen…
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CLINICAL_TRIALS trial_result · 2008-03-04Clinical Trial Update: The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders
This completed trial evaluated the effect of gonadotropin-releasing hormone on pituitary hormones in menstrual-cycle mood-related disorders.…
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CLINICAL_TRIALS trial_result · 2008-02-21Clinical Trial Update: Luteal Phase Administration of Paroxetine for the Treatment of PMDD [Phase 3]
A Phase 3 clinical trial evaluated luteal-phase paroxetine for treating Premenstrual Dysphoric Disorder; the study status is completed.
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FDA approval · 2008-02-14FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)
FDA approved a supplemental application for fluoxetine from Chartwell Governmental & Specialty RX, LLC.
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FDA approval · 2008-02-05FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for Apotex Corp. to market a generic paroxetine hydrochloride product (PAROXETINE HYDROCHLORIDE).
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FDA approval · 2008-01-31FDA Approved: FLUOXETINE — Original Application (QUALLENT PHARMACEUTICALS HEALTH LLC)
FDA approved the original application for a generic fluoxetine hydrochloride product from Quallent Pharmaceuticals Health LLC.
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FDA approval · 2008-01-11FDA Approved: SERTRALINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application for a sertraline generic product from Heritage Pharmaceuticals (Avet), authorizing changes to the ap…
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FDA approval · 2008-01-08FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals Inc.'s sertraline hydrochloride generic under an Original Application. The approval provides a generic…
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CLINICAL_TRIALS trial_result · 2007-12-27Clinical Trial Update: Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder [Phase 3]
Phase 3 trial evaluating the combination of levonorgestrel and ethinyl estradiol for premenstrual dysphoric disorder has completed.
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CLINICAL_TRIALS trial_result · 2007-12-27Clinical Trial Update: Fibromyalgia and Psychiatric Symptoms Among PMS and PMDD Patients
This completed clinical trial evaluated fibromyalgia and psychiatric symptoms in patients with Premenstrual Syndrome and Premenstrual Dyspho…
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CLINICAL_TRIALS trial_result · 2007-12-27Clinical Trial Update: Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder [Phase 3]
The document notes the completion of a Phase 3 trial evaluating a levonorgestrel/ethinyl estradiol combination for Premenstrual Dysphoric Di…
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FDA approval · 2007-12-26FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for SERTRALINE HYDROCHLORIDE (generic) from Aurobindo Pharma Limited, updating the regulatory status…
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CLINICAL_TRIALS trial_result · 2007-12-07Clinical Trial Update: A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria [Phase 4]
A Phase 4 placebo-controlled trial evaluated the onset of action of paroxetine for Premenstrual Dysphoric Disorder and has completed.
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FDA approval · 2007-10-25FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride, a generic sertraline product, under the ANDA.
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FDA approval · 2007-10-10FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
FDA approved Lannett Company's supplemental application for fluoxetine hydrochloride, a generic version of fluoxetine.
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FDA approval · 2007-09-28FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc., resulting in an approved label update for this g…
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CLINICAL_TRIALS trial_result · 2007-08-20Clinical Trial Update: Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder (PMDD) [NA]
A completed clinical trial assessed levetiracetam for Premenstrual Dysphoric Disorder; results are not provided in the summary.