Calendar

Week of May 1, 2023

May 1, 2023approval1221d agoDALFAMPRIDINE — FDA approvaldalfampridine ER

Sponsor: ACCORD HLTHCARE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →dalfampridine ER →fda approvals ↗

May 1, 2023approval1221d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

May 1, 2023approval1221d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

May 1, 2023approval1221d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

May 1, 2023approval1221d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

May 1, 2023approval1221d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

May 1, 2023approval1221d agoDALFAMPRIDINE — FDA approvalSolaxa Inc

Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

May 3, 2023approval1219d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

Sponsor: VERTEX PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

May 3, 2023approval1219d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

full page →ivacaftor →fda approvals ↗

May 3, 2023approval1219d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

May 3, 2023approval1219d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of May 8, 2023

May 8, 2023approval1214d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

Sponsor: HQ SPCLT PHARMA. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

May 8, 2023approval1214d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

May 8, 2023approval1214d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

full page →odevixibat →fda approvals ↗

May 9, 2023approval1213d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗

May 9, 2023approval1213d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗

May 10, 2023approval1212d agoVERQUVO (VERICIGUAT) — FDA approvalMerck & Co., Inc.

Sponsor: MSD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

May 11, 2023approval1211d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

May 11, 2023approval1211d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: NOVITIUM PHARMA. Form: SOLUTION. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

May 11, 2023approval1211d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

May 12, 2023approval1210d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

May 12, 2023approval1210d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

full page →atezolizumab →fda approvals ↗

May 12, 2023approval1210d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

full page →atezolizumab →fda approvals ↗

Week of May 15, 2023

May 15, 2023approval1207d agoINREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approvalfedratinib

Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL

full page →fedratinib →fda approvals ↗

May 18, 2023approval1204d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

May 18, 2023approval1204d agoMIEBO (PERFLUOROHEXYLOCTANE) — FDA approvalBausch & Lomb Corp

Sponsor: BAUSCH AND LOMB INC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

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May 18, 2023approval1204d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

May 18, 2023approval1204d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

Sponsor: BOEHRINGER INGELHEIM. Form: INJECTABLE. Route: INJECTION

full page →CYLTEZO →fda approvals ↗

May 18, 2023approval1204d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →upadacitinib tartrate ER →fda approvals ↗