Narcolepsy
📧 Sign up to get email alerts when something new happens for Narcolepsy.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Oryza Pharmaceuticals Inc.)
FDA approved a supplemental application for a generic mixed amphetamine salts product consisting of dextroamphetamine saccharate, amphetamin…
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved Cranbury Pharmaceuticals' supplemental application for dextroamphetamine (generic) under ANDA 203644, enabling the generic …
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application from Sun Pharmaceutical to market a generic product containing a combination of dextroamphetamine an…
-
FDA approval · 2022-02-14FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA granted supplemental approval for Teva Pharmaceuticals USA, Inc. to market a generic combination product containing four amphetamine…
-
FDA approval · 2022-02-14FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for the combination of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfat…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2022-02-10FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for Amphetamine Sulfate (amphetamine) by Amneal Pharmaceuticals NY LLC under ANDA211139, marking a r…
-
FDA approval · 2022-02-09FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for sodium oxybate submitted by Hikma Pharmaceuticals USA Inc.
-
FDA approval · 2022-02-09FDA Approved: XYWAV — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approved a supplemental application for XYWAV, the calcium, magnesium, potassium, and sodium oxybates product from Jazz Pharmaceuticals.…
-
FDA approval · 2022-01-31FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva's generic combination of four amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroam…
-
FDA approval · 2021-12-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved a new generic combination amphetamine product (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, …
-
FDA label_change · 2021-12-09FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Sodium Oxybate (Hikma Pharmaceuticals USA Inc.), resulting in changes to the product's labeling.
-
FDA approval · 2021-11-26FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Golden State Medical Supply, Inc.)
FDA approved a generic drug product comprising four amphetamine salts (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine …
-
FDA approval · 2021-10-20FDA Approved: SUNOSI — Supplemental Application (Axsome Therapeutics, Inc.)
The FDA approval record concerns a supplemental application for Sunosi (solriamfetol) from Axsome Therapeutics, with the submission status s…
-
FDA approval · 2021-09-29FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic product containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphe…
-
FDA approval · 2021-08-12FDA 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 product's regulatory ap…
-
FDA approval · 2021-07-19FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)
FDA approved a supplemental application for MethyLin (methylphenidate hydrochloride) submitted by Shionogi under NDA 021419.
-
CLINICAL_TRIALS trial_result · 2021-07-06Clinical Trial Update: A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness [Phase 2]
Phase 2 study evaluating safety and effectiveness of ADX-N05 for excessive daytime sleepiness in narcolepsy completed.
-
FDA approval · 2021-06-25FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
The FDA approved a supplemental application for methylphenidate hydrochloride submitted by Granules Pharmaceuticals Inc.
-
FDA approval · 2021-06-25FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals Inc.)
FDA approves Camber Pharmaceuticals' supplemental application for methylphenidate hydrochloride tablets, providing a new generic option.
-
FDA approval · 2021-06-25FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for methylphenidate hydrochloride by Rising Pharma Holdings, Inc., effectively authorizing a generic…
-
FDA approval · 2021-06-23FDA Approved: XYWAV — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approved a supplemental application for XYWAV (calcium, magnesium, potassium, and sodium oxybates) from Jazz Pharmaceuticals.
-
FDA approval · 2021-06-22FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for methylphenidate hydrochloride from Rising Pharma Holdings, Inc., signaling an approved suppl…
-
FDA approval · 2021-06-14FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methylphenidate hydrochloride from SpecGx LLC.
-
FDA approval · 2021-05-11FDA Approved: MODAFINIL — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application from Apotex Corp. for Modafinil, authorizing a generic version of the wakefulness-promoting drug…
-
FDA approval · 2021-04-22FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic product containing four amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate,…