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Aural Fullness And/or Autophony (DiBartolomeo's Syndrome) PatulEnd® Is Only Orphan
Aural fullness and/or autophony (DiBartolomeo's Syndrome) PatulEnd® is only Orphan product that is NORD approved, now drug-free, with Exclusivity for treating the Patulous Eustachian Tube disorder. . Can it be included in the Eustachian tube or middle ear disorders. Thank you.
In accordance with Orphan Drug Application of April 23, 1996 submitted pursuant to Section 526 of the Federal Food Drug and Cosmetic Act for the designation of PatulEND® Orphan Drug for the treatment of the rare, Orphan, Patulous Eustachian tube anomaly disorder.
Approval was determined by the Office of Orphan Products Development (HF35) Food and Drug Administration, February 18, 1997, by Marlene E. Haffner, MD. M.P.H.
Rear Admiral United States Public Service, Director, Office of Orphan Product Development
Dr. Rynne, Thank you for " making a difference. Joseph Di Bartolomeo, MDF, FACS, UCLA, H & N.
In accordance with Orphan Drug Application of April 23, 1996 submitted pursuant to Section 526 of the Federal Food Drug and Cosmetic Act for the designation of PatulEND® Orphan Drug for the treatment of the rare, Orphan, Patulous Eustachian tube anomaly disorder.
Approval was determined by the Office of Orphan Products Development (HF35) Food and Drug Administration, February 18, 1997, by Marlene E. Haffner, MD. M.P.H.
Rear Admiral United States Public Service, Director, Office of Orphan Product Development
Dr. Rynne, Thank you for " making a difference. Joseph Di Bartolomeo, MDF, FACS, UCLA, H & N.
