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Australia approves first capsule-form Viagra generic Posted 14/09/2018

Singapore-based iX Biopharma announced on 6 August 2018 that it had received approval from Australia’s Therapeutic Goods Administration (TGA) for its sildenafil drug, which is delivered in an oral capsule for treating erectile dysfunction.

iX Biopharma’s drug is a generic version of Pfizer’s blockbuster erectile dysfunction drug Viagra (sildenafil). The drug, which was previously known as XCalibur, will be marketed under the name Silcap in Australia. Unlike other Viagra generics in the market, which are delivered in tablet form, Silcap, is delivered using a novel, small capsule, giving an alternative dose form for patients who cannot swallow tablets.

iX Biopharma received approval from the TGA for Silcap on 31 July 2018 for 25 mg and 50 mg doses of sildenafil in pack sizes of 4, 8 and 12 capsules.

Silcap is iX Biopharma’s second treatment for erectile dysfunction and is the first capsule-form sildenafil generic to be approved for marketing in Australia.

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Source: iX Biopharma, TGA

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