Narcolepsy
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Sign up freeTop drugs studied for this disease
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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.
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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…
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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.
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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…
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FDA approval · 2021-06-14FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methylphenidate hydrochloride from SpecGx LLC.
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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…
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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,…
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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.
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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…
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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…
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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.
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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.
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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…
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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.
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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).
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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…
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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…
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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).
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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 …
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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…
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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.
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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.
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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.
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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…
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FDA approval · 2019-12-13FDA Approved: ARMODAFINIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for ARMODAFINIL submitted by Mylan Pharmaceuticals Inc.