Schizophrenia

• FDA approval · 2020-11-17
  FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved Solco Healthcare US, LLC's supplemental application to market a generic risperidone product.

• FDA approval · 2020-11-16
  FDA Approved: OLANZAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva Pharmaceuticals' olanzapine product under an ANDA.

• FDA approval · 2020-11-09
  FDA Approved: OLANZAPINE — Supplemental Application (Dr. Reddy's Laboratories Ltd.)

  FDA approved a supplemental application for olanzapine from Dr. Reddy's Laboratories, establishing a generic version of the drug. The action…

• FDA approval · 2020-11-09
  FDA Approved: OLANZAPINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved a supplemental application for olanzapine filed by Dr. Reddy's Laboratories Inc., indicating regulatory approval related to…

• FDA approval · 2020-10-30
  FDA Approved: PALIPERIDONE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for paliperidone (generic) submitted by NorthStar RxLLC.

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• FDA approval · 2020-10-30
  FDA Approved: QUETIAPINE EXTENDED RELEASE — Supplemental Application (ACI Healthcare USA, Inc.)

  FDA approves a supplemental application for a generic quetiapine extended-release product by ACI Healthcare USA, Inc.

• FDA approval · 2020-10-29
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.

• FDA approval · 2020-10-28
  FDA Approved: RISPERIDONE — Supplemental Application (Natco Pharma USA LLC)

  The FDA approved a supplemental application for Risperidone from Natco Pharma USA LLC under an ANDA.

• FDA approval · 2020-10-26
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries Inc)

  FDA approved a generic version of chlorpromazine hydrochloride under Original Application for Sun Pharmaceutical Industries Inc, expanding a…

• FDA approval · 2020-10-22
  FDA Approved: OLANZAPINE — Original Application (Eugia US LLC)

  FDA approved the Original Application for olanzapine submitted by Eugia US LLC. The approval covers a generic olanzapine product indicated f…

• FDA approval · 2020-10-19
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for risperidone by Amneal Pharmaceuticals LLC.

• FDA approval · 2020-09-11
  FDA Approved: ILOPERIDONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for iloperidone from Mylan Pharmaceuticals Inc., authorizing a generic version of iloperidone to…

• FDA approval · 2020-08-27
  FDA Approved: ARISTADA — Supplemental Application (Alkermes, Inc.)

  The FDA approves a supplemental application for ARISTADA (aripiprazole lauroxil) from Alkermes, Inc.

• FDA approval · 2020-08-27
  FDA Approved: ARISTADA INITIO — Supplemental Application (Alkermes, Inc.)

  The FDA approved a supplemental application for ARISTADA INITIO (aripiprazole lauroxil) from Alkermes, authorizing its use as a long-acting …

• EMA approval · 2020-07-31
  EMA Authorised: Olazax (olanzapine) — Glenmark Pharmaceuticals s.r.o.

  Olazax (olanzapine) has been authorised for schizophrenia and bipolar disorder in the European Union.

• FDA approval · 2020-07-29
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  FDA approved a supplemental application for Versacloz (clozapine) submitted by TruPharma LLC.

• FDA approval · 2020-07-26
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental ANDA for Clozapine from Mylan Pharmaceuticals, approving a generic version of Clozapine under ANDA 201824.

• FDA approval · 2020-07-09
  FDA Approved: FLUPHENAZINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the generic version of fluphenazine hydrochloride (Amneal) through an original ANDA, for the treatment of schizophrenia.

• FDA approval · 2020-07-07
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Eugia US LLC)

  The FDA approved Eugia US LLC's generic chlorpromazine hydrochloride under an Original Application (ANDA 211816).

• EMA approval · 2020-06-16
  EMA Authorised: Olazax Disperzi (olanzapine) — Glenmark Pharmaceuticals s.r.o.

  Authorised olazax disperzi (olanzapine) for schizophrenia and bipolar disorder in the EU.

• FDA approval · 2020-04-23
  FDA Approved: ZYPREXA RELPREVV — Supplemental Application (H2-Pharma LLC)

  The FDA approved a supplemental application for ZYPREXA RELPREVV (olanzapine pamoate) submitted by H2-Pharma LLC.

• FDA approval · 2020-04-23
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company.

• FDA approval · 2020-04-22
  FDA Approved: ZYPREXA RELPREVV — Supplemental Application (H2-Pharma LLC)

  The FDA approved a supplemental application for ZYPREXA RELPREVV (olanzapine pamoate) submitted by H2-Pharma LLC.

• FDA approval · 2020-04-21
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  The FDA approved Eli Lilly's supplemental application for ZYPREXA Intramuscular (olanzapine), finalizing approval for the intramuscular form…

• FDA approval · 2020-04-21
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company, related to the orodispersible tab…