Narcolepsy
📧 Sign up to get email alerts when something new happens for Narcolepsy.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2017-01-04FDA Approved: EVEKEO — Supplemental Application (Azurity Pharmaceuticals, Inc.)
FDA approved a supplemental application for EVEKEO, a brand-name amphetamine sulfate product from Azurity Pharmaceuticals, under ANDA 200166…
-
FDA approval · 2017-01-04FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for a generic fixed-dose combination of four amphetamine salts (dextroamphetamine saccharate, amphet…
-
FDA approval · 2016-12-27FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application from Prasco Laboratories for a generic dextroamphetamine sulfate product.
-
FDA approval · 2016-11-28FDA Approved: ARMODAFINIL — Original Application (Natco Pharma USA LLC)
The FDA approved Natco Pharma USA LLC's original application for armodafinil, enabling generic armodafinil to enter the market.
-
FDA approval · 2016-11-07FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for methylphenidate hydrochloride from Rising Pharma Holdings, Inc., a generic stimulant indicated for…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2016-10-28FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for a methylphenidate hydrochloride generic product manufactured by SpecGx LLC.
-
FDA approval · 2016-10-28FDA Approved: DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for a generic product containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetam…
-
FDA approval · 2016-10-28FDA Approved: DEXTROAMPHETAMINE SULFATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for dextroamphetamine sulfate by SpecGx LLC under an ANDA. This action confirms the approval of a ge…
-
FDA approval · 2016-10-25FDA Approved: DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application from SpecGx LLC for dextroamphetamine sulfate extended-release, clearing a generic extended-rele…
-
FDA approval · 2016-09-27FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for four amphetamine salt products (dextroamphetamine saccharate, amphetamine aspartate, dextro…
-
FDA approval · 2016-07-28FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved Amneal Pharmaceuticals of New York LLC's generic methylphenidate hydrochloride product under an Original Application. It is…
-
FDA approval · 2016-06-23FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for sodium oxybate filed by Hikma Pharmaceuticals USA Inc.
-
FDA approval · 2016-06-15FDA Approved: MODAFINIL — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for Modafinil from Alembic Pharmaceuticals Limited. The approval confirms the ability to market the …
-
FDA approval · 2016-03-16FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (Lupin Pharmaceuticals,Inc.)
FDA approved Lupin's dextroamphetamine sulfate as an original ANDA, enabling a generic version of the stimulant for ADHD and narcolepsy.
-
FDA approval · 2016-02-16FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approved an original application for a generic mixed amphetamine salts product (dextroamphetamine and amphetamine salts) from Amneal Pha…
-
FDA approval · 2016-02-09FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for methylphenidate from Sandoz Inc, resulting in an expanded/updated authorization for the product.
-
FDA approval · 2016-01-28FDA Approved: MODAFINIL — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for modafinil filed by Bionpharma Inc. to market a generic wakefulness-promoting drug.
-
FDA approval · 2016-01-20FDA Approved: ARMODAFINIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for armodafinil filed by Mylan Pharmaceuticals, granting regulatory approval for the indicated s…
-
FDA approval · 2015-11-23FDA Approved: DEXTROAMPHETAMINE SULFATE — Original Application (KVK-Tech, Inc.)
FDA approved a generic version of dextroamphetamine sulfate under an Original Application for KVK-Tech, Inc., making this product available …
-
EMA approval · 2015-11-20Narcolepsy treatment recommended for approval
The European Medicines Agency recommends approving a treatment for narcolepsy, indicating a potential new therapy option for patients with n…
-
FDA approval · 2015-11-13FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals,Inc.)
FDA approved Lupin Pharmaceuticals' generic methylphenidate hydrochloride product via Original Application, making a generic version of meth…
-
FDA approval · 2015-09-22FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Camber Pharmaceutical Inc)
The FDA approved Camber Pharmaceutical's methylphenidate hydrochloride as an Original Application, providing a generic version of the stimul…
-
FDA approval · 2015-08-20FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Actavis's generic dextroamphetamine/amphetamine salt product. The approval updates labeling and …
-
FDA approval · 2015-08-17FDA Approved: SODIUM OXYBATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium oxybate by Hikma Pharmaceuticals USA Inc., updating its regulatory status for this produc…
-
FDA approval · 2015-08-14FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals,Inc.)
FDA approved Lupin Pharmaceuticals' methylphenidate hydrochloride generic under an Original Application (ANDA 204602); this provides a gener…