Calendar

pharmadog

Week of Sep 29, 2025

Oct 2, 2025approval315d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

full page →teclistamab →fda approvals ↗

Oct 2, 2025approval315d agoTALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

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

full page →talquetamab →fda approvals ↗

Oct 2, 2025approval315d agoZEPZELCA (LURBINECTEDIN) — FDA approvallurbinectedin

Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS

full page →lurbinectedin →fda approvals ↗

Oct 2, 2025approval315d agoTEPADINA AND SODIUM CHLORIDE (THIOTEPA) — FDA approvalRevalesio Corp

Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 2, 2025approval315d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗

Oct 2, 2025approval315d agoTECENTRIQ HYBREZA (ATEZOLIZUMAB AND HYALURONIDASE-TQJS) — FDA approval(atezolizumab + hyaluronidase (human recombinant))

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

full page →(atezolizumab + hyaluronidase (human recombinant)) →fda approvals ↗

Oct 2, 2025approval315d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗

Oct 2, 2025approval315d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

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

full page →METHYLIN ER →fda approvals ↗

Oct 2, 2025approval315d agoCROMOLYN SODIUM — FDA approvalVitalgenics LLC

Sponsor: TEVA PHARMS. Form: SOLUTION. Route: INHALATION

full page →fda approvals ↗

Oct 2, 2025approval315d agoMETADATE ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE ER

Sponsor: LANNETT CO INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METADATE ER →fda approvals ↗

Oct 2, 2025approval315d agoMETADATE ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE ER

Sponsor: LANNETT CO INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METADATE ER →fda approvals ↗

Oct 2, 2025approval315d agoEYDENZELT (AFLIBERCEPT-BOAV) — FDA approvalEYDENZELT

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

full page →EYDENZELT →fda approvals ↗

Oct 2, 2025approval315d agoSEVOFLURANE — FDA approvalSEVOFLURANE

Sponsor: BAXTER HLTHCARE. Form: LIQUID. Route: INHALATION

full page →SEVOFLURANE →fda approvals ↗

Oct 2, 2025approval315d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Oct 2, 2025approval315d agoVANCOMYCIN HYDROCHLORIDE — FDA approvalSamson Medical Technologies LLC

Sponsor: STERISCIENCE. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 2, 2025approval315d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 2, 2025approval315d agoPILOCARPINE HYDROCHLORIDE — FDA approvalPILOCARPINE HYDROCHLORIDE

Sponsor: FDC LTD. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →PILOCARPINE HYDROCHLORIDE →fda approvals ↗

Oct 2, 2025approval315d agoOSELTAMIVIR PHOSPHATE — FDA approvalF. Hoffmann-La Roche Ltd

Sponsor: ZHEJIANG POLY PHARM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Oct 2, 2025approval315d agoMIRTAZAPINE — FDA approvalmirtazapine ODT

Sponsor: ANNORA PHARMA. Form: TABLET. Route: ORAL

full page →mirtazapine ODT →fda approvals ↗

Oct 2, 2025approval315d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHARTWELL MOLECULAR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Oct 2, 2025approval315d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: CHARTWELL MOLECULAR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Oct 2, 2025approval315d agoETRAVIRINE — FDA approvalETRAVIRINE

Sponsor: BIONPHARMA. Form: TABLET. Route: ORAL

full page →ETRAVIRINE →fda approvals ↗

Oct 3, 2025approval314d agoDEFLAZACORT — FDA approvalDEFLAZACORT

Sponsor: ZYDUS LIFESCIENCES. Form: SUSPENSION. Route: ORAL

full page →DEFLAZACORT →fda approvals ↗

Oct 3, 2025approval314d agoDOVONEX (CALCIPOTRIENE) — FDA approvalcalcipotriene

Sponsor: LEO PHARMA AS. Form: CREAM. Route: TOPICAL

full page →calcipotriene →fda approvals ↗

Oct 3, 2025approval314d agoNAPROXEN — FDA approvalNAPROXEN

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

full page →NAPROXEN →fda approvals ↗

Oct 3, 2025approval314d agoCLOMIPHENE CITRATE — FDA approvalCLOMIPHENE CITRATE

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

full page →CLOMIPHENE CITRATE →fda approvals ↗

Oct 3, 2025approval314d agoDOVONEX (CALCIPOTRIENE) — FDA approvalcalcipotriene

Sponsor: LEO PHARMA AS. Form: OINTMENT. Route: TOPICAL

full page →calcipotriene →fda approvals ↗

Oct 3, 2025approval314d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 3, 2025approval314d agoOMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →omeprazole DR →fda approvals ↗

Oct 3, 2025approval314d agoDOCOSANOL — FDA approvalPL Developments Copiague LLC

Sponsor: DR REDDYS. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Oct 3, 2025approval314d agoAXTLE (PEMETREXED DIPOTASSIUM) — FDA approvalAXTLE

Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS

full page →AXTLE →fda approvals ↗

Oct 4, 2025approval313d agoZORYVE (ROFLUMILAST) — FDA approvalArcutis Biotherapeutics, Inc.

Sponsor: ARCUTIS. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Week of Oct 6, 2025

Oct 6, 2025approval311d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Oct 6, 2025approval

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Week of Sep 29, 2025

Week of Oct 6, 2025