Do not turn a historical page into current prescribing eligibility
FDA oncology entries below describe specific withdrawn indications, not every possible use of a drug. Confirm current complete labeling separately. Source-quality holds describe the available rendering, not necessarily a defect in the original prescribing document. Official supplements remain separate; they do not repair an RX rendering.
Find an alert or source limitation
84 matching source limits / alerts.
Use drug/source terms only, never patient identifiers. Search works without JavaScript.
Indication / approval alert
XPOVIO: withdrawn DLBCL indication
FDA lists withdrawal of the accelerated approval for adults with relapsed/refractory DLBCL after at least two systemic-therapy lines, including DLBCL arising from follicular lymphoma. This alert does not declare other selinexor indications withdrawn. Indication-specific withdrawal; check Drugs@FDA for current complete labeling. Not a blanket all-use or market-availability decision.
FDA event date: 2026-04-30. Selected source checked 2026-09-08.
Indication / approval alert
EXKIVITY: withdrawn EGFR-exon-20 NSCLC indication
FDA lists withdrawal for adult locally advanced/metastatic EGFR-exon-20-insertion NSCLC progressing on or after platinum chemotherapy. An old RX monograph does not establish current approval. Indication-specific withdrawal; check Drugs@FDA for current complete labeling. Not a blanket all-use or market-availability decision.
FDA event date: 2024-07-15. Selected source checked 2026-09-08.
Indication / approval alert
PEPAXTO: withdrawn relapsed/refractory myeloma indication
FDA lists withdrawal of the dexamethasone combination after at least four prior myeloma regimens, with disease refractory to a proteasome inhibitor, immunomodulatory agent and CD38-directed antibody. Indication-specific withdrawal; check Drugs@FDA for current complete labeling. Not a blanket all-use or market-availability decision.
FDA event date: 2024-02-23. Selected source checked 2026-09-08.
Indication / approval alert
MAKENA and generics: approval withdrawn
FDA withdrew approval of MAKENA and its generics for prevention of recurrent preterm birth. A historical RX entry is not evidence of current FDA approval for that use. Regulatory status alert, not a dosing recommendation or complete availability search.
FDA event date: 2023-04-06. Selected source checked 2026-09-08.
Indication / approval alert
OCALIVA / obeticholic acid: U.S. approval withdrawn
FDA withdrew NDA 207999 and three obeticholic acid ANDAs effective November 24, 2025. Retained historical renal text does not establish current U.S. prescribing eligibility. Selected dated regulatory event; not an exhaustive market-status database.
FDA event date: 2025-11-24. Selected source checked 2026-09-09.
Indication / approval alert
OXBRYTA: FDA notice of voluntary market withdrawal
FDA advised clinicians to stop prescribing OXBRYTA after its voluntary withdrawal for safety concerns. This dated market-withdrawal notice is not merely an indication-specific dose restriction. Selected dated regulatory event; not an exhaustive market-status database.
FDA event date: 2024-09-26. Selected source checked 2026-09-09.
Retained observation from vearlier release
Intron A-Rebetol - source limitation
Renal/dose section is visibly truncated; no new renal summary from this rendering.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from vearlier release
Eulexin - source limitation
Renal/dose section is visibly truncated; no new renal summary from this rendering.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from vearlier release
Contepo - source limitation
Selected safety/PK import only. RX dosing table absent from returned rendering.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from vearlier release
Boniva - source limitation
Mixed formulation: oral descriptive text with injection dosing/clinical sections. No oral RX regimen imported.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from vearlier release
Imdelltra - source limitation
Only a short incomplete IMDELLTRA rendering returned. No RX renal summary imported.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.5
PEDIAZOLE - source limitation
Rendering ends during the pediatric dosing schedule; no new RX renal summary imported.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.5
POTIGA - source limitation
Historical rendering ends during an adverse-event table. Full monograph and current product status not established; no new RX renal summary imported.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.5
GAMMAGARD S/D - source limitation
Rendering ends in the indications text and refers to missing warnings; no new RX renal summary imported.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.5
EULEXIN - source limitation
Renal paragraph visibly ends mid-sentence at the CrCl description. The older F hold remains; no new RX renal summary imported.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.5
ODEFSEY - source limitation
Only renal restrictions/monitoring imported. A complete HD dosing instruction was not established in the selected rendering.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.7
MOTEGRITY - source limitation
The RX rendering contains only a short description and lacks its renal prescribing section. No new RX renal summary imported; the official DailyMed supplement is separate.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.7
LYNKUET - source limitation
Selected renal PK text imported, but the referenced renal prescribing subsection was absent from the rendering. Not a renal or dialysis dosing protocol.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.8
AXID - source limitation
The AXID capsule rendering stops after the first renal-table row (CrCl 20-50, 150 mg daily). The remaining table is absent. No new renal summary imported from this truncated source.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.8
AXID-ORAL-SOLUTION - source limitation
The oral-solution rendering contains active-treatment renal rows but ends during the maintenance table. The lower-clearance maintenance row is missing. No new renal summary imported; capsule instructions are not substituted.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.8
JASCAYD - source limitation
Selected renal pharmacokinetics are stored, but the referenced renal prescribing subsection is absent. A separate official label summary does not repair the RX rendering.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.9
ONAPGO - source limitation
The retrieved RX rendering supplies selected renal PK but not a usable renal prescribing subsection. The separate official May 2026 summary is not a repair of that rendering.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.9
VIVJOA - source limitation
The RX severe-renal permission conflicts with the retrieved DailyMed label and manufacturer safety wording. The disputed passage is stored for comparison, not as prescribing authorization. Exact-label reconciliation remains open.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v4.9
ODEFSEY - source limitation
Only renal restrictions/monitoring imported. A complete HD dosing instruction was not established in the selected rendering.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.0
PEDIAZOLE - source limitation
Rendering ends during the pediatric dosing schedule; no new RX renal summary imported. Prior source limitation retained; a returned page alone does not repair it.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.0
POTIGA - source limitation
Historical rendering ends during an adverse-event table. Full monograph and current product status not established; no new RX renal summary imported. Prior source limitation retained; a returned page alone does not repair it.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.0
MOTEGRITY - source limitation
The RX rendering contains only a short description and lacks its renal prescribing section. No new RX renal summary imported; the official DailyMed supplement is separate. Prior source limitation retained; a returned page alone does not repair it.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.0
MIRAPEX - source limitation
The URL is named mirapex, but the retrieved source body identifies MIRAPEX ER. Selected ER instructions are imported only for the ER record. Not a source for immediate-release dosing; the new IR record uses a separate exact DailyMed label.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.0
GAVRETO - source limitation
The RX text supplies a 30-89 supported PK range and prints less than15 for the severe-impairment unknown. The15-29 gap remains unreconciled; no dose or silent correction is inferred.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.2
rezdiffra - source limitation
March 2024 mirror leaves severe impairment unstudied; July 2026 official section includes severe-impairment evidence. Read the newer official card; this is a dated-source difference.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.2
wayrilz - source limitation
Selected RX rendering provides PK but omits the full categorical renal instruction. Official section 8.7 advises avoidance in severe impairment; do not invent a numeric cutoff.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.3
sovaldi - source limitation
The retrieved SOVALDI label retains a severe-renal/ESRD limitation; regimen-level HCV guidance discusses sofosbuvir-containing regimens. Exact product/regimen adjudication is required; no blended dose supplied.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.3
journavx - source limitation
Official and mirror renal paragraphs use <15 and >15 mL/min, while PK includes >=15. Exact 15 is not assigned by this tool; absolute versus indexed eGFR must be retained.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.3
sephience - source limitation
Selected renal PK information is unknown; incomplete selected sections do not establish a no-adjustment instruction or a human dose cutoff from animal findings.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.3
sulfamylon - source limitation
Historical mirror concerns mafenide 5% topical solution. Current official product-label review remains open; do not apply its findings to cream or infer a numerical renal schedule.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.3
carospir - source limitation
The suspension is not therapeutically equivalent to ALDACTONE tablets. The renal starting-amount sentence does not state a separate frequency; a tablet alternate-day schedule is not substituted.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
talzenna - source limitation
The RX moderate-renal mCRPC dose differs from the rechecked official section 2.6. Disputed mirror text is retained only to document the difference, not as prescribing permission.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
tadliq - source limitation
The printed dosage bands omit exact CrCl 30 mL/min. Do not fill the boundary or substitute an ED regimen.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
adcirca - source limitation
The printed PAH dosage bands omit exact CrCl 30 mL/min. No inferred boundary assignment.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
cyklokapron - source limitation
The printed IV serum-creatinine table repeats 2.83 mg/dL in adjacent bands. Exact boundary requires clarification; not a CrCl table.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
tigan - source limitation
The selected capsule source specifies lengthening the interval, without a fixed reduced interval, and prints indexed CrCl units. Current exact-label/method clarification remains open.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
thiola - source limitation
Index wording refers to delayed release but this monograph identifies immediate-release 100 mg tablets. Local scope follows the monograph body, not the index label.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
thiola-ec - source limitation
Index wording is nonspecific while the monograph identifies THIOLA EC delayed-release tablets. Local scope follows the body and dosage-form section.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
yutrepia - source limitation
T-index Yutrepia entry and returned body describe injection/infusion. Exact product-route identity has not been established; no YUTREPIA clinical import is made.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
imdelltra - source limitation
The returned page contains a technical-difficulties message rather than a monograph. It counts only as returned page content, not a recovered clinical monograph.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
ticlast - source limitation
The Ticlast page contains a Dymista nasal-spray description and no complete renal monograph. No clinical import is made from this mismatched partial rendering.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.4
terlivaz - source limitation
Selected RX text lacks the full pictured adjustment pathway; separately retrieved official HTML and its visually inspected figure provide the local pathway. This does not certify complete RX recovery.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.5
campral - source limitation
The inclusive contraindication at CrCl 30 or less overlaps the printed 30-50 band and differs from the retained GlobalRPh less-than-30 wording. Do not use the band as permission at exactly 30.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.5
zyloprim - source limitation
Newly retrieved oral gout initiation wording and ACR titrated maintenance must be reconciled with retained older GlobalRPh renal ceilings; a cancer-therapy dialysis row is not a gout schedule.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.5
acetazolamide - source limitation
Marked kidney dysfunction is a qualitative contraindication. No numerical cutoff or routine dialysis regimen is supplied.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.5
aphexda - source limitation
Severe-renal PK is predicted, not measured; no clinical regimen is inferred.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.6
bylvay-test - source limitation
The returned page explicitly says the RX List page cannot be found. Technical text, not a recovered drug monograph; no renal content imported.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.6
alunbrig - source limitation
Selected rendering contains renal PK and references section 2.7, but a usable renal dose section was not recovered in this review. No new regimen imported.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.6
bludigo - source limitation
Selected renal sentence names MDRD but prints mL/min without the indexing denominator. Unit ambiguity is preserved, not automatically converted.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.6
brinsupri - source limitation
Selected renal PK statement only; no dialysis or below-eGFR-15 regimen was established.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.7
cabenuva - source limitation
RX mirror retrieval failed; the new local CABENUVA card is official-label content, not an RX import.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.7
carbaglu - source limitation
RX mirror retrieval failed; renal tables are summarized from the exact official label only.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.7
carnexiv - source limitation
Selected IV vehicle guidance retained. Current commercial availability and numeric renal-severity bands were not established in this review.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.7
dostinex - source limitation
Selected small renal PK study only, not a dedicated dialysis or numerical renal dosing schedule.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.7
cafcit - source limitation
Neonatal concentration monitoring; no adult clearance-based schedule or established therapeutic target imported.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.8
parcopa - source limitation
Parcopa-titled destination renders extended-release carbidopa/levodopa text. Brand/formulation identity was not reconciled; no regimen imported from this page.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.8
carboplatin - source limitation
Carboplatin mirror loses range separators in its BSA-based renal table. Those rows were not reconstructed. Only separately legible source findings imported.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.8
bicnu - source limitation
BiCNU source wording contains broad renal non-administration and a numeric stop threshold; dated official label has differing revision fields and an ended marketing entry. Current-product/scope reconciliation remains open.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.8
carnitor-injection - source limitation
CARNITOR injection post-HD regimen is from an April 2018 mirror. Exact current official-label confirmation remains pending; not transferable to oral levocarnitine.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.8
spectracef - source limitation
SPECTRACEF prints indexed CrCl, not an unindexed Cockcroft-Gault threshold. ESRD dose is unestablished despite dialyzability data; current official-product confirmation is pending.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.8
exblifep - source limitation
EXBLIFEP RX attempts failed and exact directory destination remains unresolved. Local content is from a separately retrieved dated official label, not recovered RX content. Current-product and renal-unit reconciliation remain open.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Exact RX destination unresolved. No guessed source link is substituted.
Retained observation from v5.9
diabinese - source limitation
Current exact-product labeling and availability were not verified. This dated qualitative reference is not a recommendation to initiate chlorpropamide.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v5.9
procysbi - source limitation
The severe-renal range operator is missing from the retrieved mirror rendering. Use the separately attributed official source; do not repair this text by inference.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.0
ddavp - source limitation
The tablet RX mirror prints a 2007 revision. Only selected renal/restriction paragraphs were compared; full current-product and revision-history reconciliation remains open.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.0
Deferasirox - EXJADE tablets for oral suspension - source limitation
Manufacturer-hosted EXJADE PDF prints July 2020. Selected renal paragraphs were checked, but a later-revision/current-market reconciliation is still required.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.1
Amoxicillin / clavulanate - AUGMENTIN XR extended-release tablets - source limitation
RX mirror only: current official product labeling and availability need confirmation.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.1
Amoxicillin / clavulanate - AUGMENTIN ES-600 oral suspension - source limitation
RX mirror only; numerical renal dosing is unavailable in the selected section and is not supplied.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.1
Dabigatran - PRADAXA oral pellets (pediatric product) - source limitation
Current official oral-pellet label was not obtained. Threshold ambiguity remains unresolved; no pediatric dose is supplied.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.1
Oseltamivir - source limitation
Retrieved exact official label is dated 8/2019; retrieval in 2026 does not establish a 2026 revision.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.3
Ertugliflozin - STEGLATRO oral tablets - source limitation
RX-only selected summary. Current exact-product official label confirmation remains open.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.3
Glimepiride - AMARYL oral tablets - source limitation
Dated RX mirror; fresh exact-product official confirmation remains open.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.3
Nateglinide - STARLIX oral tablets - source limitation
Mixed dated generic/brand page. Selected renal statements preserved; current official product confirmation pending.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.3
Eslicarbazepine acetate - APTIOM tablets - source limitation
Dated RX mirror; new official-label confirmation pending.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.3
Torsemide - DEMADEX oral tablets - source limitation
RX-only summary; exact current product-label confirmation pending.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.3
Bumetanide - BUMEX oral tablets - source limitation
RX-only selected oral-product summary; current official confirmation pending.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.4
Belumosudil - REZUROCK oral tablets - source limitation
Printed renal indexing remains unresolved. Selected findings are not numerical renal-dose authorization.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.4
Belumosudil - REZUROCK oral tablets - source limitation
Printed renal indexing remains unresolved. Selected findings are not numerical renal-dose authorization.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.4
Amoxicillin - source limitation
Printed non-dialysis headings do not assign CrCl exactly 30 mL/min.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Retained observation from v6.4
Amantadine (source heading: Amantidine) - source limitation
Material renal dose/interval disagreement and overlapping boundaries; jurisdiction/product scope not reconciled.
Earlier observation retained unless explicitly marked as a v6.0 observation. No automatic source-quality closure.
Keep the evidence boundary visible
Only selected FDA events and observed source limitations are listed. This is not an exhaustive withdrawal, safety-alert, availability or current-label database. No regimen is selected and no prior clinical text is silently replaced.
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