Autism Spectrum Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-01-16FDA Approved: RYKINDO EXTENDED-RELEASE MICROSPHERES — Supplemental Application (Shandong Luye Pharmaceutical Co., Ltd.)
FDA approved a supplemental application for RyKindo Extended-Release Microspheres, a new extended-release formulation of risperidone develop…
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EMA approval · 2025-11-11EMA Authorised: Slenyto (melatonin) — RAD Neurim Pharmaceuticals EEC SARL
The EMA authorised Slenyto (melatonin) for sleep initiation and maintenance disorders and sleep disturbances associated with autism spectrum…
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FDA approval · 2025-11-04FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for RISPERIDONE from Amneal Pharmaceuticals LLC under an ANDA, authorizing a new or updated generic …
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FDA approval · 2025-10-22FDA Approved: ARIPIPRAZOLE — Original Application (QUAGEN PHARMACEUTICALS LLC)
FDA approved the original application for aripiprazole from Quagen Pharmaceuticals LLC, marking the availability of a generic aripiprazole p…
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FDA approval · 2025-09-02FDA Approved: RISPERIDONE — Original Application (Amneal Pharmaceuticals LLC)
FDA approval of a generic risperidone original application by Amneal Pharmaceuticals LLC.
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FDA approval · 2025-05-16FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)
FDA approved Westminster Pharmaceuticals, LLC's supplemental application for risperidone under an ANDA.
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FDA approval · 2025-02-18FDA Approved: ARIPIPRAZOLE — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application from Bionpharma Inc. for aripiprazole (generic), enabling its continued commercialization with the a…
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FDA approval · 2025-02-14FDA Approved: ARIPIPRAZOLE — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for aripiprazole from Bionpharma Inc., enabling the generic product to be marketed in the United Sta…
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FDA approval · 2025-01-24FDA Approved: ARIPIPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ARIPIPRAZOLE from Aurobindo Pharma Limited.
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FDA approval · 2025-01-24FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' supplemental application for aripiprazole (ARIPIPRAZOLE) under the ANDA pathway.
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FDA approval · 2025-01-24FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)
The FDA approved a supplemental application for aripiprazole from Alembic Pharmaceuticals, enabling the marketing of a generic version. This…
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FDA approval · 2025-01-24FDA Approved: ARIPIPRAZOLE — Supplemental Application (Advagen Pharma Ltd)
The FDA approved Advagen Pharma Ltd's supplemental application for aripiprazole, authorizing a generic ARIPIPRAZOLE product with the same in…
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FDA approval · 2025-01-24FDA Approved: ARIPIPRAZOLE — Supplemental Application (Apotex Corp.)
FDA approves a supplemental application from Apotex Corp. for aripiprazole (ANDA204094), authorizing changes to the generic product's approv…
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FDA approval · 2025-01-24FDA Approved: ARIPIPRAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for aripiprazole oral from Camber Pharmaceuticals, resulting in approval of this generic product's l…
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FDA approval · 2025-01-24FDA Approved: ARIPIPRAZOLE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for aripiprazole from VistaPharm, LLC, for a generic aripiprazole product.
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FDA approval · 2025-01-23FDA Approved: ARIPIPRAZOLE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Lannett's generic aripiprazole, authorizing a generic formulation of the antipsychotic.
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FDA approval · 2025-01-23FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)
FDA approved a supplemental application for risperidone from Amici Pharma, Inc., updating the drug's labeling and/or indications. This actio…
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FDA approval · 2025-01-23FDA Approved: ARIPIPRAZOLE — Supplemental Application (Advagen Pharma Ltd)
FDA approved Advagen Pharma Ltd's supplemental application for aripiprazole (ARIPIPRAZOLE) under ANDA216351.
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FDA approval · 2025-01-22FDA Approved: RISPERIDONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for risperidone from Sun Pharmaceutical Industries, Inc., indicating an update to labeling or indica…
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FDA approval · 2025-01-22FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for Risperdal M-Tab (risperidone) from Janssen Pharmaceuticals, Inc., updating the product under a s…
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FDA approval · 2025-01-13FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA supplemental approval for ARIPIPRAZOLE by Amneal Pharmaceuticals LLC under an ANDA (ANDA 203906). This document records the supplemental…
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FDA approval · 2025-01-13FDA Approved: ARIPIPRAZOLE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for aripiprazole by VistaPharm, LLC (ANDA 212870). The authorization pertains to changes to the appr…
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FDA approval · 2024-11-12FDA Approved: ARIPIPRAZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for a generic form of aripiprazole from Aurobindo Pharma Limited.
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FDA approval · 2024-09-09FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for risperidone by Amneal Pharmaceuticals LLC to bring a generic version of the medication to market…
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FDA approval · 2024-07-14FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for risperidone from Zydus Lifesciences Limited. This action authorizes a supplemental approval …