Calendar

pharmadog

Week of Sep 29, 2025

Oct 2, 2025approval332d agoTEPADINA AND SODIUM CHLORIDE (THIOTEPA) — FDA approvalRevalesio Corp

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

full page →fda approvals ↗

Oct 2, 2025approval332d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗

Oct 2, 2025approval332d 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, 2025approval332d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗

Oct 2, 2025approval332d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

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

full page →METHYLIN ER →fda approvals ↗

Oct 2, 2025approval332d agoCROMOLYN SODIUM — FDA approvalVitalgenics LLC

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

full page →fda approvals ↗

Oct 2, 2025approval332d 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, 2025approval332d 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, 2025approval332d agoEYDENZELT (AFLIBERCEPT-BOAV) — FDA approvalEYDENZELT

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

full page →EYDENZELT →fda approvals ↗

Oct 2, 2025approval332d agoSEVOFLURANE — FDA approvalSEVOFLURANE

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

full page →SEVOFLURANE →fda approvals ↗

Oct 2, 2025approval332d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Oct 2, 2025approval332d agoVANCOMYCIN HYDROCHLORIDE — FDA approvalSamson Medical Technologies LLC

Sponsor: STERISCIENCE. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Oct 2, 2025approval332d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

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

full page →fda approvals ↗

Oct 2, 2025approval332d agoPILOCARPINE HYDROCHLORIDE — FDA approvalPILOCARPINE HYDROCHLORIDE

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

full page →PILOCARPINE HYDROCHLORIDE →fda approvals ↗

Oct 2, 2025approval332d agoOSELTAMIVIR PHOSPHATE — FDA approvalF. Hoffmann-La Roche Ltd

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

full page →fda approvals ↗

Oct 2, 2025approval332d agoMIRTAZAPINE — FDA approvalmirtazapine ODT

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

full page →mirtazapine ODT →fda approvals ↗

Oct 2, 2025approval332d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

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

full page →fda approvals ↗

Oct 2, 2025approval332d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

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

full page →fda approvals ↗

Oct 2, 2025approval332d agoETRAVIRINE — FDA approvalETRAVIRINE

Sponsor: BIONPHARMA. Form: TABLET. Route: ORAL

full page →ETRAVIRINE →fda approvals ↗

Oct 2, 2025device 510k332d agoShenzhen Enmind Technology Co., Ltd. — IPL Hair Removal Device (IPL-001, IPL-002) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoNingbo Tianyi Medical Appliance Co., Ltd. — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (510k cleared)

Product code: FJK. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoGC America, Inc. — G-Bond Universal (510k cleared)PARKS AMERICA, INC

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

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Oct 2, 2025device 510k332d agoPhilips Medical Systems Nederland B.V. — Philips IntelliSpace Cardiovascular (510k cleared)

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

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoShenzhen Finicare Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) (510k cleared)

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

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoSimergent, LLC — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) (510k cleared)

Product code: FKX. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoThirona BV — LungQ 4 (510k cleared)

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

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoLiofilchem s.r.l. — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (510k cleared)Bristol-Myers Squibb Co

Product code: JWY. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoArtivion, Inc. — CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (510k cleared)ARTIVION, INC.

Product code: OHA. Advisory committee: Unknown. Type: Special

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoExemplar Medical, LLC — BreatheBand® (Model 1000) (510k cleared)

Product code: BYI. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoShenzhen Sophway Technology Co., Ltd. — 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoIngeniars S.R.L. — EasyTeleMed (2.0.2) (510k cleared)

Product code: DRG. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoApplied Medical Resources Corp. — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (510k cleared)PATH

Product code: HEW. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗

Oct 2, 2025device 510k332d agoOrthonovis, Inc. — Cannulated Screw and Kirschner (K wire) System (510k cleared)

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

full page →fda device 510k ↗

Oct 2, 2025device pma332d agoEdwards Lifesciences, LLC — PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (PMA supplement)Edwards Lifesciences Corp

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

full page →fda device pma ↗

Oct 2, 2025device pma332d agoW. L. Gore & Associates, Inc. — GORE® TAG® Conformable Thoracic Endoprosthesis (PMA supplement)

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

full page →fda device pma ↗

Oct 2, 2025device pma332d agoMedtronic Minimed, Inc. — MiniMed 670G System (PMA supplement)Medtronic USA Inc

Supplement type: Special (Immediate Track). Product code: OZP. Advisory committee: CH. Decision: APPR

full page →fda device pma ↗

Oct 2, 2025device pma332d agoMedtronic, Inc. — Percepta Bipolar CRTP; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P; (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 2, 2025device pma332d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Attesta DR (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 2, 2025device pma332d agoMedinol, Ltd. — EluNIR Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

Supplement type: 135 Review Track For 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Oct 2, 2025device pma332d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (PMA supplement)Edwards Lifesciences Corp

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

full page →fda device pma ↗

Oct 2, 2025device pma332d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (PMA supplement)Edwards Lifesciences Corp

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

full page →fda device pma ↗

Oct 2, 2025device pma332d agoBoston Scientific Corp — AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: JCW. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Oct 2, 2025device pma332d agoMedtronic, Inc. — Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Oct 2, 2025device pma332d agoMedtronic Vascular, Inc. — EverFlex Self-expanding Peripheral Stent System (PMA supplement)

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

full page →fda device pma ↗

Oct 2, 2025device pma332d agoValencia Technologies Corporation — eCoin Tibial Nerve Stimulator System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Oct 2, 2025device recall332d agoCerenovus Inc device recall (Cls I)

CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX100517, UNIFORM 6MM X 11.9 CM/FCX100611, UNIFORM 6MM X 26 CM/FCX100626, UNIFORM 7MM X 13.9 CM/FCX100713, UNIFORM 7MM X 30 CM/FCX100730, UNIFORM 8MM X 16.1 CM/FCX100816, UNIFORM 8MM X 29 CM/FCX100829, UNIFORM 3D 2MM X 2.5 CM/FCX140225, UNIFORM 3D 3MM X 3 CM/FCX140303, UNIFORM 3D 3MM X 4 CM/FCX140304, UNIFORM 3D 3MM X 6 CM/FCX140306, UNIFORM 3D 4MM X 6 CM/FCX140406, UNIFORM 3D 4MM X 8 CM/FCX140408, UNIFORM 3D 4MM X 4.5 CM/FCX140445, UNIFORM 3D 5MM X 7 CM/FCX140507, UNIFORM 3D 5MM X 12 CM/FCX140512, UNIFORM 3D 6MM X 9 CM/FCX140609, UNIFORM 3D 6MM X 15 CM/FCX140615, UNIFORM 3D 7MM X 11 CM/FCX140711, UNIFORM 3D 7MM X 17 CM/FCX140717, UNIFORM 3D 8MM X 12 CM/FCX140812, UNIFORM 3D 8MM X 20 CM/FCX140820, UNIFORM 3D 9MM X 14 CM/FCX140914, UNIFORM 3D 9MM X 22 CM/FCX140922, UNIFORM 3D 10MM X 16 CM/FCX141016, UNIFORM 3D 10MM X 25 CM/FCX141025, UNIFORM 3D 11MM X 18 CM/FCX141118, UNIFORM 3D 11MM X 27 CM/FCX141127, UNIFORM 3D 12MM X 19 CM/FCX141219, UNIFORM 3D 12MM X 30 CM/FCX141230, UNIFORM XL 5MM X 10 CM/FCX180510, UNIFORM XL 6MM X 12.2 CM/FCX180612, UNIFORM XL 7MM X 14.3 CM/FCX180714, UNIFORM XL 8MM X 13.6 CM/FCX180813, UNIFORM XL 8MM X 30 CM/FCX180830, UNIFORM XL 9MM X 15.3 CM/FCX180915, UNIFORM XL 9MM X 33 CM/FCX180933, UNIFORM XL 10MM X 17.1 CM/FCX181017, UNIFORM XL 10MM X 34 CM/FCX181034, UNIFORM XL 11MM X 18.9 CM/FCX181118, UNIFORM XL 11MM X 37 CM/FCX181137, UNIFORM XL 12MM X 20.7 CM/FCX181220, UNIFORM XL 12MM X 40 CM/FCX181240, UNIFORM XL 13MM X 43 CM/FCX181343, UNIFORM XL 14MM X 47 CM/FCX181447, UNIFORM XL 15MM X 50 CM/FCX181550, UNIFORM XL 16MM X 47 CM/FCX181647, UNIFORM XL 17MM X 50 CM/FCX181750, UNIFORM XL 18MM X 46 CM/FCX181846, UNIFORM XL 19MM X 50 CM/FCX181950, UNIFORM XL 20MM X 50 CM/FCX182050, FREEFORM MINI 1MM X 1CM/MCR091010, FREEFORM MINI 1MM X 1.5CM/MCR091015, FREEFORM MINI 1MM X 2CM/MCR091020, FREEFORM MINI 1MM X 2.5CM/MCR091025, FREEFORM MINI 1MM X 3CM/MCR091030, FREEFORM MINI 1MM X 4CM/MCR091040, FREEFORM MINI 1.5MM X 2CM/MCR091520, FREEFORM MINI 1.5MM X 2.5CM/MCR091525, FREEFORM MINI 1.5MM X 3CM/MCR091530, FREEFORM MINI 1.5MM X 4CM/MCR091540, FREEFORM MINI 2MM X 2CM/MCR092020, FREEFORM MINI 2MM X 3CM/MCR092030, FREEFORM MINI 2MM X 4CM/MCR092040, FREEFORM MINI 2MM X 6CM/MCR092060, FREEFORM MINI 2.5MM X 3.5CM/MCR092535, FREEFORM MINI 2.5MM X 4.5CM/MCR092545, FREEFORM MINI 2.5MM X 5.5CM/MCR092555, FREEFORM MINI 3MM X 4CM/MCR093040, FREEFORM MINI 3MM X 6CM/MCR093060, FREEFORM MINI 3MM X 8CM/MCR093080, FREEFORM 2MM X 2 CM/SCR120202, FREEFORM 3MM X 6 CM/SCR120306, FREEFORM 3MM X 8 CM/SCR120308, FREEFORM 4MM X 7 CM/SCR120407, FREEFORM 4MM X 10 CM/SCR120410, FREEFORM 4MM X 12 CM/SCR120412, FREEFORM 5MM X 10 CM/SCR120510, FREEFORM 5MM X 15 CM/SCR120515, FREEFORM 6MM X 10 CM/SCR120610, FREEFORM 6MM X 15 CM/SCR120615, FREEFORM 6MM X 20 CM/SCR120620, FREEFORM 7MM X 15 CM/SCR120715, FREEFORM 7MM X 21 CM/SCR120721, FREEFORM 8MM X 15 CM/SCR120815, FREEFORM 8MM X 24 CM/SCR120824, FREEFORM 9MM X 25 CM/SCR120925, FREEFORM 10MM X 30 CM/SCR121030, FREEFORM 12MM X 30 CM/SCR121230, FREEFORM 2.5MM X 5 CM/SCR122505, FREEFORM 2.5MM X 3.5 CM/SCR122535, FREEFORM 3.5MM X 9 CM/SCR123509, FREEFORM 3.5MM X 7.5 CM/SCR123575, HELIFORM SOFT 1.5MM X 4 CM/SHD100154, HELIFORM SOFT 2MM X 8 CM/SHD100208, HELIFORM SOFT 2.5MM X 10 CM/SHD100250, HELIFORM SOFT 2.5MM X 8 CM/SHD100258, HELIFORM SOFT 3MM X 8 CM/SHD100308, HELIFORM SOFT 3MM X 10 CM/SHD100310, HELIFORM SOFT 4MM X 8 CM/SHD100408, HELIFORM SOFT 4MM X 10 CM/ SHD100410, HELIFORM SOFT 5MM X 10 CM/ SHD100510, HELIFORM SOFT 5MM X 15 CM/ SHD100515, HELIFORM SOFT 6MM X 12 CM/ SHD100612, HELIFORM SOFT 6MM X 16 CM/ SHD100616, HELIFORM SOFT 7MM X 16 CM/ SHD100716, HELIFORM SOFT 7MM X 20 CM/ SHD100720, HELIFORM SOFT 8MM — Reason: Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention. — Status: Ongoing

Oct 2, 2025device recall332d agoICU Medical, Inc. device recall (Cls I)ICU MEDICAL INC/DE

IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014 — Reason: IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body. — Status: Ongoing

full page →fda device recalls ↗

Oct 2, 2025device recall332d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234; — Reason: The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model. — Status: Ongoing

full page →fda device recalls ↗

Oct 3, 2025approval331d agoDEFLAZACORT — FDA approvalDEFLAZACORT

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

full page →DEFLAZACORT →fda approvals ↗

Oct 3, 2025approval331d agoDOVONEX (CALCIPOTRIENE) — FDA approvalcalcipotriene

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

full page →calcipotriene →fda approvals ↗

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Week of Sep 29, 2025