Olaparib is listed for DrugStatusIndex cancer drug review with a working oncology status of FDA approved or FDA-recognized use under approved labeling.
FDA Regulatory Database

Is Olaparib
FDA approved?

DrugStatusIndex.com provides a plain-English status page for Olaparib, including FDA approval status, prescription classification, compounding context, pricing information, and regulatory notes.

FDA Approved
FDA status
PARP Inhibitor / Ovarian
Drug category
Coverage and prior authorization vary by plan, dose, pharmacy, and diagnosis.
Last reviewed
Drug status summary

Olaparib

FDA Approved

Lynparza

Brand names
Breast
Prescription status
$14,000-$17,000 / month
Compounded status
Prostate Cancer
Confusion level
Commercial FDA-approved oncology products or approved generics may be available; compounding is generally not appropriate when approved products meet patient needs.
FDA Approved Approved for commercial use in the US
Not Approved Not cleared by FDA for use
Investigational Under review or in clinical trials
Rx Only Prescription required — not OTC
FDA approval status

Olaparib approval status and regulatory context

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What DrugStatusIndex currently shows

Lynparza

Regulatory note: Manufacturer or patient-assistance savings may apply for brand/specialty products
FDA status
FDA Approved
Drug category
PARP Inhibitor / Ovarian
Prescription status
$14,000-$17,000 / month
Availability note
$13,000-$16,000 specialty estimate

Index review fields

Review status
Check whether Olaparib is FDA approved, its cancer treatment category, prescription status, availability, and key regulatory notes for 2026.
Last checked
https://www.cancer.gov/about-cancer/treatment/drugs/cancer-drugs
Published
Yes
Page URL
https://drugstatusindex.com/is-olaparib-fda-approved/
Pricing and access

Olaparib pricing information

Pricing can vary by dose, pharmacy, insurance coverage, manufacturer savings, coupon programs, market availability, and current supply conditions.

Retail estimate
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Estimated cash or retail pricing range when available.

Coupon estimate
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Discount-card or pharmacy coupon estimate when available.

Pricing last checked
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Pricing data should be rechecked before making financial or treatment decisions.

Pricing summary

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Coverage and savings notes

Manufacturer savings: {pricing_manufacturer_savings}

Insurance note: {pricing_insurance_note}

Sources and verification

Verify Olaparib directly with trusted source material

DrugStatusIndex.com is an informational resource. FDA status, availability, and pricing should be independently verified using official FDA resources, pharmacy data, prescribing information, and licensed healthcare guidance.

FDA / regulatory source
Olaparib FDA Approval Status (2026) – Approved or Not?
Pricing source
{pricing_source_url}

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Informational resource only
DrugStatusIndex.com reflects publicly available FDA regulatory data and does not provide medical advice, diagnosis, treatment recommendations, pharmacy recommendations, or legal/regulatory advice. Always consult a licensed healthcare provider before making any medical decision.
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