Insulin Glulisine Recombinant

For diabetes mellitus. Sold as Apidra, Apidra Solostar. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Insulin Glulisine Recombinant (sold as Apidra, Apidra Solostar), first approved Apr 16, 2004, with 2 new uses approved and 0 published complete response letters.

First approved: Apr 16, 2004
Applications: 1
New uses approved: 2
Complete response letters: 0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

APIDRA 100 UNIT/ML VIAL: $8.16 per MLBrand · 0% in a year
APIDRA SOLOSTAR 100 UNIT/ML: $10.50 per MLBrand · 0% in a year

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Apr 16, 2004	Apidra, Apidra SolostarBLA 21629 · New molecular entity	Sanofi Aventis US	17	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA