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Becaplermin
Product Approval Information - Licensing Action
Proper name: Becaplermin
Tradename: Regranex
Manufacturer: OMJ Pharmaceuticals, Inc, Manati, Puerto Rico, License #1196
Indication for Use: Treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond, and have adequate blood supply
Approval Date: 12/16/97
Type of submission: Biologics license application
Approval Letter
(PDF),
(Text)
Label (PDF)
Reviews (PDF)
Clinical (70 pages)
CMC (9 pages)
Pharmacology (68 pages)
Statistical (14 pages)
Talk Paper
Last Updated: 3/5/2001
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Date created: September 16, 2003 |
