alpelisib
alpelisib is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including VIJOICE, PIQRAY. Available dosage forms: powder, tablet, kit, granule.
Drug Details
- Generic Name
- alpelisib
- Brand Names
- VIJOICE, PIQRAY
- Application Number
- NDA215039
- Sponsor
- Novartis Pharmaceuticals Corporation
- NDC Codes
- 14
- Dosage Forms
- POWDER, TABLET, KIT, GRANULE
- Routes
- ORAL
- Active Ingredients
- ALPELISIB
Indications and Usage
1 INDICATIONS AND USAGE PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.