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U.S. Department of Health and Human Services

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Becaplermin Product Approval Information - Licensing Action 12/16/97

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)

Label (PDF)

Reviews (PDF)
    Clinical (70 pages)
    CMC (9 pages)
    Pharmacology (68 pages)
    Statistical (14 pages)