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Week of Mar 22, 2021

21

Mar 22, 2021approval1989d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗

Mar 22, 2021approval1989d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗

Mar 23, 2021approval1988d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Mar 23, 2021approval1988d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Mar 23, 2021approval1988d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Mar 23, 2021approval1988d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Mar 23, 2021approval1988d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Mar 23, 2021approval1988d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Mar 23, 2021approval1988d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

Mar 23, 2021approval1988d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

Mar 23, 2021approval1988d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

Mar 23, 2021approval1988d agoIMITREX (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

Mar 23, 2021approval1988d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Mar 23, 2021approval1988d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Mar 23, 2021approval1988d agoTIVICAY PD (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Mar 23, 2021approval1988d agoJULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Mar 23, 2021approval1988d agoDOVATO (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Mar 25, 2021approval1986d agoKARBINAL ER (CARBINOXAMINE MALEATE) — FDA approvalAYTU BIOPHARMA, INC

Sponsor: AYTU. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 26, 2021approval1985d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

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

full page →fda approvals ↗

Mar 26, 2021approval1985d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

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

full page →fda approvals ↗

Mar 26, 2021approval1985d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

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

full page →fda approvals ↗

Week of Mar 29, 2021

18

Mar 29, 2021approval1982d agoDICLOFENAC SODIUM — FDA approvalDICLOFENAC SODIUM

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DICLOFENAC SODIUM →fda approvals ↗

Mar 30, 2021approval1981d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗

Mar 30, 2021approval1981d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

full page →nivolumab →fda approvals ↗

Mar 30, 2021approval1981d agoVYXEOS (CYTARABINE) — FDA approvalMeitheal Pharmaceuticals Inc

Sponsor: JAZZ PHARMS THERAP. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Mar 30, 2021approval1981d agoMETOLAZONE — FDA approvalMETOLAZONE

Sponsor: INNOGENIX. Form: TABLET. Route: ORAL

full page →METOLAZONE →fda approvals ↗

Mar 31, 2021approval1980d agoTYVASO (TREPROSTINIL) — FDA approvalUNITED THERAPEUTICS Corp

Sponsor: UNITED THERAP. Form: SOLUTION. Route: INHALATION

full page →fda approvals ↗

Mar 31, 2021approval1980d 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 ↗

Mar 31, 2021approval1980d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: ACTAVIS LABS FL. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 31, 2021approval1980d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Mar 31, 2021approval1980d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Mar 31, 2021approval1980d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Mar 31, 2021approval1980d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 1, 2021approval1979d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

Apr 1, 2021approval1979d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 1, 2021approval1979d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 1, 2021approval1979d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →alirocumab →fda approvals ↗

Apr 1, 2021approval1979d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →alirocumab →fda approvals ↗

Apr 2, 2021approval1978d agoLETROZOLE — FDA approvalLETROZOLE

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

full page →LETROZOLE →fda approvals ↗