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Jun 13, 2023approval1177d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: STRIDES PHARMA INTL. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Jun 13, 2023approval1177d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: WES PHARMA INC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 13, 2023approval1177d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

full page →odevixibat →fda approvals ↗

Jun 14, 2023approval1176d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 14, 2023approval1176d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 14, 2023approval1176d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 14, 2023approval1176d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 14, 2023approval1176d agoABRILADA (ADALIMUMAB-AFZB) — FDA approvalABRILADA

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

full page →ABRILADA →fda approvals ↗

Jun 15, 2023approval1175d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jun 15, 2023approval1175d agoTRIUMEQ PD (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Jun 15, 2023approval1175d agoCOLUMVI (GLOFITAMAB-GXBM) — FDA approvalglofitamab

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

full page →glofitamab →fda approvals ↗

Jun 15, 2023approval1175d agoBREVIBLOC (ESMOLOL HYDROCHLORIDE) — FDA approvalESMOLOL HYDROCHLORIDE

Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →ESMOLOL HYDROCHLORIDE →fda approvals ↗

Jun 16, 2023approval1174d agoBYOOVIZ (RANIBIZUMAB-NUNA) — FDA approvalBYOOVIZ

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →BYOOVIZ →fda approvals ↗

Jun 16, 2023approval1174d agoROLVEDON (EFLAPEGRASTIM-XNST) — FDA approvalSpectrum Pharmaceuticals Inc

Sponsor: SPECTRUM PHARMS. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →fda approvals ↗

Jun 16, 2023approval1174d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jun 17, 2023approval1173d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Jun 17, 2023approval1173d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Week of Jun 19, 2023

18

Jun 20, 2023approval1170d agoVYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — FDA approvalARGENX SE

Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jun 20, 2023approval1170d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗

Jun 20, 2023approval1170d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗

Jun 20, 2023approval1170d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

Jun 20, 2023approval1170d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

Jun 20, 2023approval1170d agoJARDIANCE (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

Jun 20, 2023approval1170d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗

Jun 20, 2023approval1170d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗

Jun 21, 2023approval1169d agoZTALMY (GANAXOLONE) — FDA approvalganaxolone

Sponsor: IMMEDICA PHARMA. Form: SUSPENSION. Route: ORAL

full page →ganaxolone →fda approvals ↗

Jun 21, 2023approval1169d agoZTALMY (GANAXOLONE) — FDA approvalganaxolone

Sponsor: IMMEDICA PHARMA. Form: SUSPENSION. Route: ORAL

full page →ganaxolone →fda approvals ↗

Jun 22, 2023approval1168d agoEVEROLIMUS — FDA approvalEVEROLIMUS

Sponsor: BRECKENRIDGE. Form: TABLET. Route: ORAL

full page →EVEROLIMUS →fda approvals ↗

Jun 22, 2023approval1168d agoEVEROLIMUS — FDA approvalEVEROLIMUS

Sponsor: BRECKENRIDGE. Form: TABLET. Route: ORAL

full page →EVEROLIMUS →fda approvals ↗

Jun 22, 2023approval1168d agoEVEROLIMUS — FDA approvalEVEROLIMUS

Sponsor: BRECKENRIDGE. Form: TABLET. Route: ORAL

full page →EVEROLIMUS →fda approvals ↗

Jun 22, 2023approval1168d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Jun 22, 2023approval1168d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

Sponsor: MOLNLYCKE HLTH. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Jun 22, 2023approval1168d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

Jun 23, 2023approval1167d agoMYORISAN (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jun 23, 2023approval1167d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: APOTEX INC. Form: TABLET. Route: ORAL

full page →IBANDRONATE SODIUM →fda approvals ↗

Week of Jun 26, 2023

15

Jun 26, 2023approval1164d agoPREGABALIN — FDA approvalViatris Inc

Sponsor: ALKEM LABS LTD. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jun 26, 2023approval1164d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 26, 2023approval1164d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 26, 2023approval1164d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Jun 26, 2023approval1164d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Jun 26, 2023approval1164d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Jun 26, 2023approval1164d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 26, 2023approval1164d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Jun 26, 2023approval1164d agoRYSTIGGO (ROZANOLIXIZUMAB-NOLI) — FDA approvalrozanolixizumab

Sponsor: UCB INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →rozanolixizumab →fda approvals ↗

Jun 26, 2023approval1164d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗

Jun 26, 2023approval1164d agoHADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →HADLIMA →fda approvals ↗

Jun 28, 2023approval1162d 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 ↗

Jun 28, 2023approval1162d agoCAPLYTA (LUMATEPERONE TOSYLATE) — FDA approvallumateperone tosylate

Sponsor: INTRA-CELLULAR. Form: CAPSULE. Route: ORAL

full page →lumateperone tosylate →fda approvals ↗

Jun 29, 2023approval1161d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jun 29, 2023approval1161d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →guselkumab →fda approvals ↗