# Comparability protocol for 22.5 mg tablets (NADA # 141-526)

> **NIH FDA R01** · ANIVIVE LIFESCIENCES, INC · 2023 · $250,000

## Abstract

Project Summary/Abstract
The protocol is to add an additional strength of Laverdia tablets. Successful execution of this
protocol will result in the addition of a 22.5 mg tablet to the existing portfolio of 2.5 mg, 10 mg
and 50 mg tablets. There will be no changes to the manufacturing process or facility currently
approved for Laverdia tablets. Approved analytical procedures will be used to assess and test
the new tablet strength.

## Key facts

- **NIH application ID:** 10672808
- **Project number:** 1R01FD007800-01
- **Recipient organization:** ANIVIVE LIFESCIENCES, INC
- **Principal Investigator:** David Bruyette
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2023
- **Award amount:** $250,000
- **Award type:** 1
- **Project period:** 2022-12-01 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10672808

## Citation

> US National Institutes of Health, RePORTER application 10672808, Comparability protocol for 22.5 mg tablets (NADA # 141-526) (1R01FD007800-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10672808. Licensed CC0.

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