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Week of Apr 6, 2026

31

Apr 10, 2026approval90d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 10, 2026approval90d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

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

full page →LOSARTAN POTASSIUM →fda approvals ↗

Apr 10, 2026approval90d agoMETHYLPREDNISOLONE — FDA approvalPFIZER INC

Sponsor: TIANJIN TIANYAO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 10, 2026approval90d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval90d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval90d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval90d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval90d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

Apr 10, 2026approval90d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval90d agoLIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% (LIDOCAINE HYDROCHLORIDE) — FDA approvalLaryng-O-Jet

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Laryng-O-Jet →fda approvals ↗

Apr 10, 2026approval90d agoDILTIAZEM HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 10, 2026approval90d agoMETHYLPREDNISOLONE — FDA approvalMEDROL

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →MEDROL →fda approvals ↗

Apr 10, 2026approval90d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: STRIDES PHARMA INTL. Form: FOR SUSPENSION. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Apr 10, 2026device pma90d agoBoston Scientific — Lead Port Plug Model 6996 (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoZoll Circulation, Inc. — TherOx Downstream System (PMA supplement)

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

full page →fda device pma ↗

Apr 10, 2026device pma90d agoAutoGenomics, Inc. — AvertD and AvertD Buccal Sample Collection Kit (PMA supplement)NEOGENOMICS INC

Supplement type: Real-Time Process. Product code: QZH. Advisory committee: TX. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoBoston Scientific Corp — Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: NIK. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoBoston Scientific — Wrench Kit Model 6501 (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoBoston Scientific — Vein Pick Model 6541 (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoBoston Scientific Corporation — TheraSphere (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Apr 10, 2026device pma90d agoDePuy Orthopaedics, Inc. — Ceramax Ceramic Hip System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30

full page →fda device pma ↗

Apr 10, 2026device pma90d agoMicroTransponder, Inc. — Vivistim® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30

full page →fda device pma ↗

Apr 10, 2026device pma90d agoBoston Scientific — Lead Stylets, Straight, X-Soft Models 5003, 5004, 5005 Lead Stylets, Long Tapered, Soft Models 5012, 5013, 5014 (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWP. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoBoston Scientific — Straight Lead Stylets Limber Models 6033, 6034; Straight Lead Stylets Firm Models 6036, 6037; J Shaped Lead Stylets Limb (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: NVN. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoMedtronic — HEARTWARE VENTRICULAR ASSIST SYSTEM (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Apr 10, 2026device pma90d agoBoston Scientific — ACUITY X4 Connector Tool Model 4625 AICD Lead Stylets Firm Model 6971 AICD Lead Stylets Soft Model 6972 Suture S (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

Supplement type: Special (Immediate Track). Product code: NPW. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoBoston Scientific — Fixation Tool Model 6616 (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: NVN. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoImpulse Dynamics (Usa), Inc. — GUARDIO/VESTA Charger (PMA supplement)

Supplement type: Real-Time Process. Product code: QFV. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoOrganox Limited — OrganOx metra® System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma90d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30

full page →fda device pma ↗

Week of Apr 13, 2026

19

Apr 13, 2026approval87d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Apr 13, 2026approval

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