Calendar

pharmadog

Week of Sep 22, 2025

Sep 23, 2025approval341d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

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

full page →LABETALOL HYDROCHLORIDE →fda approvals ↗

Sep 23, 2025approval341d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: UBI. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

Sep 23, 2025approval341d agoMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE CD

Sponsor: AYTU BIOPHARMA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →METADATE CD →fda approvals ↗

Sep 23, 2025approval341d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoXELSTRYM (DEXTROAMPHETAMINE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: SYSTEM. Route: TRANSDERMAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoDYANAVEL XR 20 (AMPHETAMINE) — FDA approvalDYANAVEL XR 20

Sponsor: TRIS PHARMA INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →DYANAVEL XR 20 →fda approvals ↗

Sep 23, 2025approval341d agoRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalRITALIN LA

Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →RITALIN LA →fda approvals ↗

Sep 23, 2025approval341d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

Sep 23, 2025approval341d agoERYTHROMYCIN — FDA approvalAbon Pharmaceuticals LLC

Sponsor: ABON PHARMS LLC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

Sep 23, 2025approval341d agoLEUPROLIDE ACETATE — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: EUGIA PHARMA. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Sep 23, 2025approval341d agoADDERALL XR 10 (AMPHETAMINE ASPARTATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoRIVASTIGMINE — FDA approvalrivastigmine ER

Sponsor: YICHANG HUMANWELL. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →rivastigmine ER →fda approvals ↗

Sep 23, 2025approval341d agoAZSTARYS (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvalSandoz Inc

Sponsor: COMMAVE THERAP. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoAZITHROMYCIN — FDA approvalPFIZER INC

Sponsor: CHARTWELL RX. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

Sep 23, 2025approval341d agoZOLADEX (GOSERELIN) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

Sep 23, 2025approval341d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

Sep 23, 2025approval341d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: HERITAGE PHARMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

Sep 23, 2025approval341d agoBREVIBLOC (ESMOLOL HYDROCHLORIDE) — FDA approvalESMOLOL HYDROCHLORIDE

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

full page →ESMOLOL HYDROCHLORIDE →fda approvals ↗

Sep 23, 2025approval341d agoSUPPRELIN LA (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

full page →fda approvals ↗

Sep 23, 2025approval341d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

Sep 23, 2025approval341d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoAPTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: RHODES PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

Sep 23, 2025approval341d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

Sep 23, 2025approval341d agoDYANAVEL XR (AMPHETAMINE) — FDA approvalamfetamine ER

Sponsor: TRIS PHARMA INC. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →amfetamine ER →fda approvals ↗

Sep 23, 2025approval341d agoVANTAS (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

full page →fda approvals ↗

Sep 23, 2025approval341d agoALVIMOPAN — FDA approvalPar Pharmaceutical Inc

Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025approval341d agoCOTEMPLA XR-ODT (METHYLPHENIDATE) — FDA approvalAYTU BIOPHARMA, INC

Sponsor: NEOS THERAPS INC. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Sep 23, 2025device 510k341d agoHangzhou SHINING3D Dental Technology Co., Ltd. — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (510k cleared)

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

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoOlympus Winter & Ibe GmbH — Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) (510k cleared)

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

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoCanyon Medical, Inc. — Polyvinyl Alcohol Embolic Microspheres (510k cleared)

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

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoBiolinq Incorporated — Biolinq Shine Autonomous Time-in-Range Microsensor (510k cleared)

Product code: SFU. Advisory committee: Clinical Chemistry. Type: Direct

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoHimaging Technology (Shanghai) Co., Ltd. — Himaging Bronchscope System (510k cleared)

Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoIschemaview, Inc. — Rapid Aortic Measurements (510k cleared)

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

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoIntuitive Surgical, Inc. — Ion Endoluminal System (IF1000) (510k cleared)INTUITIVE SURGICAL INC

Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoZenflow, Inc. — Zenflow Spring Scope (510k cleared)

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

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoLuminance Medical Ventures, Inc. — Luminance Red Cold Sore Device (TN1927G) (510k cleared)

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

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoEdwards Lifesciences, LLC — Edwards MC3 Tricuspid annuloplasty ring (4900) (510k cleared)Edwards Lifesciences Corp

Product code: KRH. Advisory committee: Cardiovascular. Type: Abbreviated

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoAirs Medical, Inc. — SwiftSight-Brain (510k cleared)AVITA Medical, Inc.

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

full page →fda device 510k ↗

Sep 23, 2025device 510k341d agoM/s. Meril Endo Surgery Private Limited. — PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture (510k cleared)

Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Special

full page →fda device 510k ↗

Sep 23, 2025device pma341d agoMedtronic Vascular, Inc. — VenaSeal Closure System (PMA supplement)

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

full page →fda device pma ↗

Sep 23, 2025device pma341d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30

full page →fda device pma ↗

Sep 23, 2025device pma341d agoMedtronic Vascular, Inc. — Abre Venous Self-expanding Stent System (PMA supplement)

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

full page →fda device pma ↗

Sep 23, 2025device pma341d agoLungpacer Medical USA, Inc. — AeroPace® System (PMA supplement)

Supplement type: Real-Time Process. Product code: SDL. Advisory committee: AN. Decision: APPR

full page →fda device pma ↗

Sep 23, 2025device recall341d agoBecton Dickinson & Co. device recall (Cls II)BECTON DICKINSON & CO

BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971. — Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data. — Status: Ongoing

full page →fda device recalls ↗

Sep 23, 2025device recall341d agoBecton Dickinson & Co. device recall (Cls II)BECTON DICKINSON & CO

BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008. — Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data. — Status: Ongoing

full page →fda device recalls ↗

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Week of Sep 22, 2025