Reconstructed Annual Counts of FDA-Approved Freeze-Dried Drugs

U.S. FDA-approved freeze-dried drug products from the 1950s to the 2010s were reconstructed from a published graphic. The dataset provides approximate annual and decadal counts, showing a strong increase from a few products in early decades to over one hundred in the 2000s and approximately 290 in the 2010s. It includes the annotated source image and spreadsheet to enable inspection of the digitisation process.

Use Cases

• Analyzing long-term growth trends in lyophilised drug development based on decadal aggregates.
• Benchmarking modern freeze-dried product approval rates against historical data.
• Teaching data reconstruction and digitisation techniques using the provided annotated source materials.
• Discussing regulatory trends for injectable drug products over a multi-decade span.

Strengths

• Provides a transparent, reproducible reconstruction with the annotated source image and spreadsheet included.
• Covers a long temporal range from the 1950s to the 2010s.
• Released under a permissive CC-BY-4.0 license.

Limitations

• Data is approximate, derived from graphical digitisation rather than primary regulatory records.
• Column names and exact row count are not specified in the provided metadata.
• The most recent data point is from the 2010s, lacking coverage for the current decade.

Provenance

Source

Graphic published by LyoHub, reconstructed by Geoff Smith.

Collection Method

Graphical digitisation of a published figure using Microsoft Excel.

Time Range

1950s to 2010s.

Freshness

Last updated 2026-03-24.

Geography

United States.