The US FDA has accepted the filing of the new drug application for its ciclesonide nasal aerosol, according to Nycomed and Sunovion. The product is an HFA formulation of ciclesonide delivered by a metered dose device for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis in patients 12 years old and older. Sunovion (formerly Sepracor) owns the US rights and will commercialize the product if approved by the FDA.
“We are pleased with the FDA’s acceptance of the NDA filing for ciclesonide HFA nasal aerosol,” commented Nycomed Executive VPAnders Ullman; “With Sunovion we have a strong partner in the United States, committed to developing ciclesonide to offer a new therapeutic option for the millions of individuals suffering with seasonal and perennial allergies.”
Sunovion already markets two other ciclesonide nasal product: Omnaris nasal spray and the Alvesco HFA MDI. It also markets Xopenex and Brovana inhalation products.
Nycomed was recently acquired by Takeda.
Read the Nycomed press release.
Read the Sunovion press release.
