Calendar

pharmadog

Week of Oct 27, 2025

Oct 28, 2025approval292d agoTRIUMEQ PD (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalTICAGRELOR

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

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Oct 28, 2025approval292d agoDROSPIRENONE AND ESTRADIOL (DROSPIRENONE) — FDA approvalExeltis USA Inc

Sponsor: NOVAST LABS. Form: TABLET. Route: ORAL

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Oct 28, 2025approval292d agoJULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

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Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

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Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

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

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Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

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Oct 28, 2025approval292d agoDOVATO (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

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Oct 28, 2025device 510k292d agoVolcano Corporation (Dba Philips Image Guided Therapy Device — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter (510k cleared)

Product code: OBJ. Advisory committee: Cardiovascular. Type: Special

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Oct 28, 2025device 510k292d agoCg Medtech Co., Ltd. — UniSpace® TPLIF Cage (510k cleared)

Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

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Oct 28, 2025device 510k292d agoBaylis Medical Technologies, Inc. — PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch (510k cleared)Medical Care Technologies Inc.

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

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Oct 28, 2025device 510k292d agoBoston Scientific Corporation — TheraSphere 360 Y-90 Management Platform (510k cleared)BOSTON SCIENTIFIC CORP

Product code: LLZ. Advisory committee: Radiology. Type: Traditional

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Oct 28, 2025device 510k292d agoWellell, Inc. — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr (510k cleared)

Product code: JOW. Advisory committee: Cardiovascular. Type: Special

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Oct 28, 2025device 510k292d agoBodycad Laboratories, Inc. — Fine Osteotomy (510k cleared)Barr Laboratories Inc

Product code: HRS. Advisory committee: Orthopedic. Type: Special

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Oct 28, 2025device 510k292d agoTyber Medical, LLC — Navigated Instruments (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Traditional

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Oct 28, 2025device 510k292d agoShofu Dental Corporation — ZIRCONOMER P (510k cleared)

Product code: EMA. Advisory committee: Dental. Type: Traditional

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Oct 28, 2025device 510k292d agoNeocis, Inc. — Yomi S Robotic System (510k cleared)

Product code: PLV. Advisory committee: Dental. Type: Traditional

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Oct 28, 2025device pma292d agoCorcym S.r.l. — PERCEVAL SUTURELESS HEART VALVE (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

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Oct 28, 2025device pma292d agoJohnson & Johnson Surgical Vision, Inc. — Healon EndoCoat PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet PRO II Dual Pack Sodium Hya (PMA supplement)JOHNSON & JOHNSON

Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30

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Oct 28, 2025device pma292d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

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Oct 28, 2025device pma292d agoMedtronic, Inc. — Aurora EV ICD (DVEA3E4) (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

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Oct 28, 2025device pma292d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

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Oct 28, 2025device pma292d agoABBOTT MEDICAL — Aveir VR Leadless Pacemaker; Aveir Leadless Pacemaker (Right Atrium); Aveir Leadless Pacemaker (Right Ventricle) (PMA supplement)

Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30

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Oct 28, 2025device pma292d agoCorcym S.r.l. — Perceval Sutureless Heart Valve (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

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Oct 28, 2025device pma292d agoAed Battery Exchange, LLC — DBP-1400-ABE and DBP-2003- ABE (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MKJ. Advisory committee: CV. Decision: APPR

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Oct 28, 2025device pma292d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: QIT. Advisory committee: OP. Decision: APPR

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Oct 28, 2025device recall292d agoBaxter Healthcare Corporation device recall (Cls II)Baxter Healthcare Corp

Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff. — Reason: Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits. — Status: Ongoing

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Oct 28, 2025device recall292d agoIllumina, Inc. device recall (Cls II)ILLUMINA, INC.

Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205 — Reason: An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user. — Status: Ongoing

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Oct 29, 2025approval291d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

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Oct 29, 2025approval291d agoNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (HYDROCORTISONE) — FDA approvalET-800

Sponsor: AMNEAL. Form: SOLUTION/DROPS. Route: OTIC

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Oct 29, 2025approval291d agoJUBBONTI (DENOSUMAB-BBDZ) — FDA approvalJUBBONTI

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

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Oct 29, 2025approval291d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

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

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Oct 29, 2025approval291d agoDENOSUMAB-DSSB — FDA approvaldenosumab biosimilar

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

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Oct 29, 2025approval291d agoCONEXXENCE (DENOSUMAB-BNHT) — FDA approvalCONEXXENCE

Sponsor: FRESENIUS KABI USA LLC. Form: INJECTION

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Oct 29, 2025approval291d agoOSENVELT (DENOSUMAB-BMWO) — FDA approvalOSENVELT

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

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Oct 29, 2025approval291d agoOSVYRTI (denosumab-desu) — FDA approvalOSVYRTI

Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

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Oct 29, 2025approval291d agoPOSACONAZOLE — FDA approvalPOSACONAZOLE

Sponsor: MSN. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗

Oct 29, 2025approval291d agoPIFELTRO (DORAVIRINE) — FDA approvaldoravirine

Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

full page →doravirine →fda approvals ↗

Oct 29, 2025approval291d agoDELSTRIGO (DORAVIRINE) — FDA approval(doravirine + lamivudine + tenofovir disoproxil fumarate)

Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

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Oct 29, 2025approval291d agoAUKELSO (DENOSUMAB-KYQQ) — FDA approvalAUKELSO

Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION

full page →AUKELSO →fda approvals ↗

Oct 29, 2025approval291d agoENOBY (DENOSUMAB-QBDE) — FDA approvalENOBY

Sponsor: HIKMA PHARMACEUTICALS USA INC. Form: SOLUTION. Route: INJECTION

full page →ENOBY →fda approvals ↗

Oct 29, 2025approval291d agoBILPREVDA (DENOSUMAB-NXXP) — FDA approvalBILPREVDA

Sponsor: SHANGHAI HENLIUS BIOTECH. Form: INJECTABLE. Route: INJECTION

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Oct 29, 2025approval291d agoVARENICLINE TARTRATE — FDA approvalVARENICLINE TARTRATE

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →VARENICLINE TARTRATE →fda approvals ↗

Oct 29, 2025approval291d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

full page →cemiplimab →fda approvals ↗

Oct 29, 2025approval291d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

Oct 29, 2025recall291d agoGraviti Pharmaceuticals Private Limited recall (Cls II)Graviti Pharmaceuticals Inc

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03. — Reason: Failed Tablet/Capsule Specifications — Status: Ongoing

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Oct 29, 2025recall291d agoLannett Company Inc. recall (Cls II)Lannett Co Inc

Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46 — Reason: Failed Dissolution Specifications — Status: Ongoing

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Oct 29, 2025recall291d agoThe Harvard Drug Group LLC recall (Cls II)Almatica Pharma LLC

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). — Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . — Status: Ongoing

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Week of Oct 27, 2025