Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-01-30FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approves Alembic Pharmaceuticals Limited's supplemental application for a lamotrigine chewable dispersible formulation, adding this dosa…
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FDA approval · 2026-01-30FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for a generic fixed-dose combination of olanzapine and fluoxetine, expanding access to this ant…
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FDA approval · 2026-01-30FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company.
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FDA approval · 2026-01-30FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for the olanzapine and fluoxetine combination, expanding/adjusting its labeling under Teva's ove…
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FDA approval · 2026-01-30FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for the olanzapine and fluoxetine combination (olanzapine + fluoxetine) submitted by Par Health USA,…
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FDA approval · 2026-01-28FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for divalproex sodium submitted by BluePoint Laboratories.
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EMA approval · 2026-01-23EMA Authorised: Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (aripiprazole) — Mylan Pharmaceuticals Limited
EMA authorised Aripiprazole Mylan Pharma (generic aripiprazole) for schizophrenia and bipolar disorder.
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FDA approval · 2026-01-22FDA Approved: OLANZAPINE — Supplemental Application (Modavar Pharmaceuticals LLC)
The FDA approved Modavar Pharmaceuticals LLC's supplemental application to market a generic olanzapine product.
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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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FDA approval · 2026-01-14FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for a fixed-dose combination of olanzapine and fluoxetine, enabling generic marketing of the pr…
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FDA approval · 2026-01-14FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for a fixed-dose combination of olanzapine and fluoxetine, adding its use for depressive episod…
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FDA approval · 2026-01-13FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for the generic combination of olanzapine and fluoxetine, manufactured by Par Health USA, LLC.
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EMA approval · 2026-01-12EMA Authorised: Abilify (aripiprazole) — Otsuka Pharmaceutical Netherlands B.V.
The EMA authorised Abilify (aripiprazole) by Otsuka Pharmaceutical Netherlands B.V. for schizophrenia and bipolar disorder in the European U…
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FDA approval · 2026-01-08FDA Approved: LAMOTRIGINE — Original Application (Torrent Pharmaceuticals Limited)
FDA approved an original ANDA for lamotrigine from Torrent Pharmaceuticals Limited, authorizing a generic lamotrigine product for use in app…
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EMA approval · 2026-01-07EMA Authorised: Olanzapine Viatris (previously Olanzapine Mylan) (olanzapine) — Viatris Limited
The EMA has authorised Olanzapine Viatris for schizophrenia and bipolar disorder; the marketing authorization holder is Viatris Limited.
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FDA approval · 2026-01-07FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)
The FDA approved Accord Healthcare Inc.'s supplemental application for quetiapine (generic), indicating approval of a modification to an alr…
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FDA approval · 2026-01-06FDA Approved: OLANZAPINE — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for Olanzapine submitted by Strides Pharma Science Limited. This action approves a supplemental …
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FDA approval · 2026-01-06FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Olanzapine by Macleods Pharmaceuticals Limited, supporting a generic version of the drug.
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FDA approval · 2025-12-31FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Lamotrigine from Aurobindo Pharma Limited, authorizing the marketing of a generic Lamotrigine pr…
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FDA approval · 2025-12-18FDA Approved: HALOPERIDOL — Original Application (Creekwood Pharmaceuticals LLC)
FDA approved Creekwood Pharmaceuticals' generic haloperidol under an original ANDA (ANDA 218162).
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FDA approval · 2025-12-03FDA Approved: OLANZAPINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for olanzapine from Torrent Pharmaceuticals Limited (ANDA 091415), expanding access to a generic ola…
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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 · 2025-10-23FDA Approved: OLANZAPINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for olanzapine from Dr. Reddy's Laboratories Limited.
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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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EMA approval · 2025-10-09EMA Authorised: Adasuve (loxapine) — Ferrer Internacional S.A.
The EMA authorised Adasuve (loxapine) by Ferrer Internacional S.A. for use in schizophrenia and bipolar disorder.