FDA approves lidocaine ointment generic from Vitruvias Therapeutics

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FDA approves lidocaine ointment generic from Vitruvias Therapeutics

Genéricos/Novedades | Posted 13/10/2017 0 Post your comment

US-based generics maker Vitruvias Therapeutics (Vitruvias) announced on 29 September 2017 that it had received approval of a new drug application from the US Food and Drug Administration (FDA) for a new drug.

The FDA entry shows that the lidocaine ointment 5% received agency approval on the 25 September 2017. The drug is an anaesthetic to be used on serious cuts or lesions, for both emergency and home use. It is a prescription-only product.

Vitruvias developed the drug with Sunny Pharmtech, a Taiwan-based active pharmaceutical ingredient (API) and drugmaker.

This is the first generic drug approval for both companies and is part of a joint development agreement that the companies say now includes eight products. The joint application was filed in November 2016. It received first-cycle approval after a 10-month review, a feat that only 9% of this type of application manages to achieve.

The drug is expected to be on the market by the end of 2017 and will be manufactured by Canada-based Halo Pharma.

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Source: US FDA, Sunny Pharmtech