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Asset / Drug

Capecitabine

Drug and asset intelligence for Capecitabine with 14 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
8
Catalysts
6
Stage
Development stage unavailable

Sponsor company

Amneal Pharmaceuticals →

Mechanism of action

Chemotherapy

Recent signals(8)

StrategyAugust 5, 2026

FDA Approval Process Update for Capecitabine ANDA204345 by Dr. Reddy's

Reddy's has submitted an Abbreviated New Drug Application (ANDA) for Capecitabine, currently under standard review.

RegulatoryAugust 5, 2026

FDA Grants Approval Status for Capecitabine ANDA204741 by Amneal Pharmaceuticals

The FDA has granted an approval status of 'AP' for Amneal Pharmaceuticals' ANDA204741 for Capecitabine.

Strategy
July 13, 2026

FDA Grants AP Status for Dr. Reddy's Capecitabine ANDA204345

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Dr. Reddy's Capecitabine.

CompetitiveJuly 13, 2026

Amneal Pharmaceuticals submits supplemental ANDA for Capecitabine

Amneal Pharmaceuticals has submitted a supplemental abbreviated new drug application (ANDA) for Capecitabine.

StrategyJuly 9, 2026

FDA Accepts ANDA for Capecitabine by Reliance Life

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Capecitabine submitted by Reliance Life.

StrategyJuly 9, 2026

FDA Grants AP Status for Capecitabine ANDA210203 by Hetero Labs

Hetero Labs has received an Abbreviated Approval (AP) for their ANDA210203 application for Capecitabine.

ClinicalJuly 7, 2026

Study on Utidelone's Efficacy in HER-2 Negative Advanced Breast Cancer

A randomized controlled study is evaluating the efficacy of Utidelone Capsule versus Utidelone Injection in combination with Capecitabine for HER-2 negative advanced breast cancer.

RegulatoryJune 21, 2026

FDA Approves Supplemental Application for Capecitabine by Accord Healthcare

The FDA has approved a supplemental application for Capecitabine submitted by Accord Healthcare.

Upcoming milestones

No catalysts indexed for this entity yet.

Related catalysts(6)

Topline Data

— Capecitabine

July 13, 2026 · N/A

Topline Data

Amneal Pharmaceuticals — Capecitabine

July 13, 2026 · N/A

Topline Data

Hetero Labs — Capecitabine

July 9, 2026 · N/A

Topline Data

— Capecitabine

July 9, 2026 · N/A

Topline Data

Beijing Biostar Pharmaceuticals Co., Ltd. — Capecitabine

July 7, 2026 · N/A

Topline Data

— Capecitabine

June 21, 2026 · N/A

Indications

Breast Cancer →

Therapeutic areas

Breast Cancer →
Chemotherapy →
Oncology →
Oncology · Breast Cancer →
Oncology · Chemotherapy →

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