Narcolepsy
📧 Sign up to get email alerts when something new happens for Narcolepsy.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2021-02-11FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc.
-
FDA approval · 2021-02-11FDA Approved: XYWAV — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA approved a supplemental application for XYWAV, the calcium/magnesium/potassium/sodium oxybates formulation from Jazz Pharmaceuticals…
-
FDA approval · 2021-01-29FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Ascent Pharmaceuticals, Inc.)
FDA approved a generic methylphenidate hydrochloride product under an Original Application (ANDA 207417) from Ascent Pharmaceuticals, Inc. f…
-
FDA approval · 2021-01-28FDA Approved: MODAFINIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application for modafinil submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
-
FDA approval · 2021-01-22FDA Approved: AMPHETAMINE SULFATE — Original Application (SpecGx LLC)
FDA approved the Original Application for amphetamine sulfate as a generic drug, filed by SpecGx LLC.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS trial_result · 2021-01-13Clinical Trial Update: Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy [Phase 2]
Phase 2 clinical trial evaluating the effects of JZP-110 on driving performance in adults with narcolepsy and excessive daytime sleepiness h…
-
FDA approval · 2021-01-13FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Rhodes Pharmaceuticals L.P.)
FDA approves Rhodes Pharmaceuticals' original ANDA for a four-salt generic amphetamine product indicated for attention-deficit/hyperactivity…
-
FDA approval · 2020-12-18FDA Approved: MODAFINIL — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for modafinil from Rising Pharma Holdings, Inc., resulting in a labeling change for the product.
-
CLINICAL_TRIALS trial_result · 2020-12-08Clinical Trial Update: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy [Phase 1]
Phase 1 trial evaluating TAK-925 in healthy volunteers and narcolepsy patients has completed with results posted.
-
CLINICAL_TRIALS trial_result · 2020-11-18Clinical Trial Update: Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy [Phase 1]
Phase 1 trial update for TAK-925 in healthy volunteers and narcolepsy patients; study completed with results posted.
-
FDA approval · 2020-10-27FDA Approved: AMPHETAMINE SULFATE — Original Application (Epic Pharma LLC)
FDA approved the Original Application for amphetamine sulfate as a generic drug manufactured by Epic Pharma LLC (ANDA 213980).
-
FDA approval · 2020-10-13FDA Approved: WAKIX — Original Application (Harmony Biosciences, LLC)
FDA approved WAKIX (pitolisant hydrochloride) from Harmony Biosciences as the original application for the treatment of narcolepsy in adults…
-
FDA approval · 2020-09-25FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate by Hikma Pharmaceuticals USA Inc., finalizing a supplement to the existing NDA fo…
-
CLINICAL_TRIALS trial_result · 2020-09-04Clinical Trial Update: Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients [Phase 2]
Phase 2 trial evaluating THN102 for safety and efficacy in reducing sleepiness in narcolepsy patients has completed with results posted.
-
FDA approval · 2020-08-19FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' methylphenidate hydrochloride generic under an original application (ANDA 205135).
-
FDA approval · 2020-07-23FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Solco Healthcare US,LLC)
FDA approved Solco Healthcare US, LLC's original application for methylphenidate hydrochloride, a generic medication indicated for ADHD and …
-
FDA approval · 2020-07-21FDA Approved: XYWAV — Original Application (Jazz Pharmaceuticals, Inc.)
FDA approved XYWAV, a lower-sodium oxybate formulation, under an original application by Jazz Pharmaceuticals for the treatment of narcoleps…
-
FDA approval · 2020-07-21FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc., updating the existing NDA.
-
FDA approval · 2020-03-30FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)
FDA approved an original ANDA for methylphenidate hydrochloride (generic) manufactured by Ascend Laboratories, LLC.
-
FDA approval · 2020-03-11FDA Approved: AMPHETAMINE SULFATE — Original Application (Solco Healthcare US, LLC)
FDA approves the original application for amphetamine sulfate (generic) to be marketed by Solco Healthcare US, LLC.
-
FDA approval · 2020-01-08FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for methylphenidate hydrochloride manufactured by Sun Pharmaceutical Industries, Inc. This actio…
-
FDA approval · 2019-12-13FDA Approved: ARMODAFINIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for ARMODAFINIL submitted by Mylan Pharmaceuticals Inc.
-
FDA approval · 2019-12-11FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Elite Laboratories, Inc.)
The FDA approved Elite Laboratories' generic mixed amphetamine salts product under an original ANDA. The product contains four salt forms of…
-
FDA label_change · 2019-11-19FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc, resulting in labeling changes for the product.
-
FDA approval · 2019-11-19FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) from Novartis Pharmaceuticals Corporation.