Diabetic Peripheral Neuropathic Pain
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CLINICAL_TRIALS trial_result · 2020-11-02Clinical Trial Update: DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain [Phase 3]
Phase III trial update for DS-5565 in diabetic peripheral neuropathic pain has completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-10-26Clinical Trial Update: DS-5565 Phase III Study for Renal Impairment in Japanese Subjects [Phase 3]
Phase III study update for DS-5565 in renal impairment Japanese subjects has completed with results posted.
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FDA approval · 2020-10-01FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)
FDA approves a supplemental application for Cymbalta (duloxetine hydrochloride) submitted by Eli Lilly and Company.
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FDA approval · 2020-04-20FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for Cymbalta (duloxetine hydrochloride) from Eli Lilly, granting updated labeling under the NDA.
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FDA approval · 2019-08-16FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Yaopharma Co., Ltd.)
FDA approved the original application for duloxetine hydrochloride from Yaopharma Co., Ltd., granting approval for the generic product to be…
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FDA approval · 2018-07-19FDA Approved: DULOXETINE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental ANDA for a generic duloxetine product (ANDA204343). Duloxetine is indicated for major depr…
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CLINICAL_TRIALS trial_result · 2018-07-10Clinical Trial Update: A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP) [Phase 4]
Phase 4 clinical trial update for Duloxetine (LY248686) in diabetic peripheral neuropathic pain has completed with results posted in 2018.
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FDA approval · 2017-04-06FDA Approved: DULOXETINE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for duloxetine submitted by Zydus Lifesciences Limited, advancing the regulatory status of the g…
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FDA approval · 2017-03-23FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved the original application for duloxetine hydrochloride from Macleods Pharmaceuticals Limited, authorizing a generic version of d…
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FDA approval · 2017-01-04FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for Cymbalta (duloxetine hydrochloride) from Eli Lilly and Company.
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FDA approval · 2016-08-03FDA Approved: DULOXETINE — Original Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' original application for a generic duloxetine product. Duloxetine is used to treat multiple conditi…
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CLINICAL_TRIALS trial_result · 2016-06-03Clinical Trial Update: Study of the Safety, Tolerability and Efficacy of V3381 in Patients With Diabetic Peripheral Neuropathic Pain [Phase 2]
Phase 2 study evaluating the safety, tolerability and efficacy of V3381 in diabetic peripheral neuropathic pain has completed (status: COMPL…
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CLINICAL_TRIALS trial_result · 2015-12-07Clinical Trial Update: Diabetic Peripheral Neuropathic Pain (DPNP) [Phase 2]
Phase 2 clinical trial in diabetic peripheral neuropathic pain completed.
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FDA approval · 2015-08-26FDA Approved: DULOXETINE — Original Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' original application for a generic duloxetine product (ANDA 203197), establishing a generic version of…
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FDA approval · 2014-09-26FDA Approved: DULOXETINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for duloxetine from Zydus Lifesciences Limited under an ANDA. The approval involves changes to the a…
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FDA approval · 2014-06-09FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic Pharmaceuticals Limited's original ANDA for duloxetine hydrochloride, establishing a generic version of duloxetine.
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FDA approval · 2014-01-08FDA Approved: DULOXETINE — Original Application (Zydus Lifesciences Limited)
FDA approved the original application for a duloxetine generic from Zydus Lifesciences Limited, enabling marketing for the same indications …
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FDA approval · 2013-12-17FDA Approved: DULOXETINE — Original Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma, Inc.'s original application for a generic duloxetine product. The approval makes low-cost generic duloxetine av…
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FDA approval · 2013-12-11FDA Approved: DULOXETINE — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for a generic duloxetine hydrochloride product from Aurobindo Pharma Limited.
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FDA approval · 2013-12-11FDA Approved: DULOXETINE — Original Application (MARKSANS PHARMA LIMITED)
FDA approves duloxetine hydrochloride generic by Marksans Pharma Limited under an Original ANDA (ANDA 090723).
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CLINICAL_TRIALS trial_result · 2011-07-14Clinical Trial Update: Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain [Phase 2]
Phase 2 study evaluating the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain; the trial status is compl…
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CLINICAL_TRIALS trial_result · 2009-08-19Clinical Trial Update: Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP [Phase 4]
Phase 4 clinical trial update of pregabalin for peripheral neuropathic pain conditions including diabetic peripheral neuropathic pain and po…