Kit

FDA Drug Profile — StellaLife VEGA Oral Care Recovery, Vega Oral Care Recovery Peppermint, Vega Oral Care Recovery Cucumber, Vega Oral Care Recovery Spearmint, StellaLife VEGA Oral Care Recovery Kit

Drug Details

Generic Name
Kit
Brand Names
StellaLife VEGA Oral Care Recovery, Vega Oral Care Recovery Peppermint, Vega Oral Care Recovery Cucumber, Vega Oral Care Recovery Spearmint, StellaLife VEGA Oral Care Recovery Kit
Application Number
Sponsor
StellaLife, Inc.
NDC Codes
6
Dosage Forms
KIT
Routes
DENTAL, SUBLINGUAL, TOPICAL, ORAL
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE ILLUCCIX, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ILLUCCIX, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ( 1 )