Label Changes for:
Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets
October 2008
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. |
Sections Modified
USE IN SPECIFIC POPULATIONS
- Pregnancy
- Teratogenic effects
- Pediatric Use
- Initial Paragraph
- ...Prevacid was not effective in patients with symptomatic GERD 1 month to less than 1 year of age in a multicenter...
double-blind, placebo controlled study.
- ...Prevacid was not effective in patients with symptomatic GERD 1 month to less than 1 year of age in a multicenter...
- Neonate to less than 1 year of age (new)
- Initial Paragraph
NONCLINICAL TOXICOLOGY
- Carcinogenesis, Mutagenesis, Impairment of Fertility
