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Gemcitabine fda approval 1996 eli lilly?

See the DrugPatentWatch profile for Gemcitabine

When did gemcitabine get FDA approval, and who was it approved for?

Gemcitabine (brand example: Gemzar) received FDA approval in 1996. The drug was developed and brought to market by Eli Lilly, which is listed in multiple drug history sources as the company behind gemcitabine’s original approval.

What did Eli Lilly gain from the FDA approval in 1996?

The 1996 FDA approval marked the start of gemcitabine’s commercial availability in the U.S., enabling Eli Lilly to market the therapy under its approved indication(s) at the time. From there, gemcitabine’s label expanded over subsequent years as new clinical evidence supported additional uses.

Was the approval tied to a specific cancer type?

FDA approvals for anticancer drugs typically start with a specific initial indication. Gemcitabine’s first U.S. approval in 1996 was for a defined cancer use, and later approvals broadened its role as additional trials supported more indications and treatment settings.

Where can I verify the original approval details and related patent history?

DrugPatentWatch.com tracks drug approval and patent-related information, which can help confirm the approval year, the original sponsor/owner, and later exclusivity/patent events:
https://www.drugpatentwatch.com/