Narcolepsy
📧 Sign up to get email alerts when something new happens for Narcolepsy.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2022-09-06FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved a supplemental application for methylphenidate hydrochloride (generic product) from Cranbury Pharmaceuticals, LLC. This app…
-
FDA approval · 2022-08-22FDA Approved: XYWAV — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approved a supplemental application for XYWAV (calcium, magnesium, potassium, and sodium oxybates) from Jazz Pharmaceuticals. This perta…
-
FDA approval · 2022-08-22FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for sodium oxybate filed by Hikma Pharmaceuticals USA Inc. for its narcolepsy treatment product.
-
FDA approval · 2022-08-18FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (Cranbury Pharmaceuticals, LLC)
FDA has approved Cranbury Pharmaceuticals' original application for a generic dextroamphetamine sulfate product. The approval covers its use…
-
CLINICAL_TRIALS trial_result · 2022-08-12Clinical Trial Update: Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy [Phase 2]
Phase 2 study evaluating safety and efficacy of mazindol extended release (NLS-2) for narcolepsy and related daytime sleepiness has complete…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2022-07-08FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Lannett Company, Inc.)
FDA approved Lannett's generic combination of four amphetamine salts (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine…
-
FDA approval · 2022-07-05FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Original Application (Neolpharma, Inc.)
FDA approved an original application for a generic product containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine…
-
CLINICAL_TRIALS trial_result · 2022-03-22Clinical Trial Update: Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy [Phase 3]
Phase 3 trial update for once-nightly sodium oxybate in narcolepsy assessing excessive daytime sleepiness and cataplexy completed with poste…
-
FDA approval · 2022-03-14FDA Approved: METHYLPHENIDATE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved a generic methylphenidate product (Original Application) from Mylan Pharmaceuticals Inc., for conditions such as ADHD and narco…
-
FDA approval · 2022-02-25FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) by Amneal Pharmaceuticals LLC.
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for dextroamphetamine sulfate from Prasco Laboratories under ANDA 040776, marking an approved modifi…
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (NorthStar RxLLC)
FDA approves a supplemental application from NorthStar RxLLC for a generic combination of four amphetamine salts (dextroamphetamine sacchara…
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Lupin Pharmaceuticals,Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for dextroamphetamine sulfate, a generic stimulant used to treat attention-…
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII — Supplemental Application (Alvogen Inc.)
FDA approved a supplemental application for Alvogen's mixed amphetamine salts tablets (CII) in multiple strengths, expanding the generic pro…
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SUNRISE PHARMACEUTICAL, INC.)
FDA approved a supplemental application for a generic product containing four amphetamine salts (dextroamphetamine saccharate, amphetamine a…
-
FDA approval · 2022-02-25FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (DR. REDDY'S LABORATORIES INC)
FDA approved a supplemental application for Amphetamine sulfate tablets from Dr. Reddy's Laboratories, indicating regulatory approval associ…
-
FDA approval · 2022-02-25FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Solco Healthcare US, LLC)
FDA approved a supplemental application for Amphetamine Sulfate submitted by Solco Healthcare US, LLC. The approval pertains to the generic …
-
FDA approval · 2022-02-25FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma LLC)
FDA approved a supplemental application for Amphetamine sulfate filed by Epic Pharma LLC.
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approves a supplemental application for a combination of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetam…
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Camber Pharmaceuticals’ generic product consisting of dextroamphetamine saccharate, amphetam…
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Elite Laboratories, Inc.)
FDA approves Elite Laboratories, Inc.'s supplemental application for a generic product containing four amphetamine salt components (dextroam…
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for dextroamphetamine sulfate from SpecGx LLC, approving a generic formulation of the ADHD/narcoleps…
-
FDA approval · 2022-02-25FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application from Sandoz to add salt forms of dextroamphetamine and amphetamine for a generic product (dextroamph…
-
FDA approval · 2022-02-25FDA Approved: AMPHETAMINE EXTENDED-RELEASE — Supplemental Application (Neos Therapeutics, LP)
The FDA approved a supplemental application for Amphetamine Extended-Release from Neos Therapeutics, LP, representing an additional regulato…
-
FDA approval · 2022-02-25FDA Approved: AMPHETAMINE SULFATE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for Amphetamine Sulfate submitted by Granules Pharmaceuticals Inc.