www.fdanews.com/articles/187928-tga-grants-first-approval-for-capsule-form-viagra-generic
TGA Grants First Approval for Capsule-Form Viagra Generic
August 8, 2018
Australia’s Therapeutic Goods Administration granted approval for Singapore-based iX Biopharma’s sildenafil drug, which is delivered in an oral capsule for treating erectile dysfunction.
Formerly known as XCalibur, the drug will be marketed under the name Silcap in Australia and sets itself apart from other Viagra generics by using a small capsule as an alternative dose form for patients who cannot swallow tablets.
Silcap, which is the company’s second treatment for erectile dysfunction, is the first capsule form sildenafil generic to be approved for marketing in Australia.