OraDisc A Approval History
FDA Approved: Yes (First approved September 29, 2004)
Brand name: OraDisc A
Generic name: amlexanox
Dosage form: Mucoadhesive Patch
Company: Access Pharmaceuticals, Inc.
Treatment for: Aphthous Ulcer
OraDisc A is a mucoadhesive patch which gradually erodes and releases the active drug amlexanox when applied to the inside of the mouth. OraDisc A is approved for the treatment of aphthous ulcers in adults and adolescents 12 years of age and older with a normal immune system.
Development History and FDA Approval Process for OraDisc A
|Sep 29, 2004||OraDisc A Access Pharmaceuticals, Inc. - Treatment for Aphthous Ulcers|
|Feb 19, 2004||Access’ OraDisc A NDA Accepted For Filing|