Prescription medicines: new or extended uses approved by the TGA

17 May 2016 - The TGA has published a list of the medicines it approved for new uses (new indications) in February & March this year.

Changes commonly include 'new uses' and 'extended uses'. A new use is where an existing medicine is approved for an additional therapeutic use. An extended use is where an exisiting medicine is approved to treat a broader range of patients, e.g. wider age range.These types of changes are called 'extension of indications'. A 'new combination' is where two or more previously registered medicines are combined into a single product.

The decision to approve an 'extension of indications' or 'new combination' for registered prescription medicines follows a comprehensive review by TGA scientists and clinicians on the safety and efficacy of the proposed use of the product.

In March, the TGA approved new uses for eltrombopag olamine (Revolade), ivacaftor (Kalydeco), collagenase clostridium histolyticum (Xiaflex) and lenalidomide (Revlimid).

In February, the TGA approved new uses for aflibercept (Eylea), ambrisentan (Volibris), liraglutide (Victoza) and omailizumab (Xolair).

The TGA did not approved any new uses/indications in January 2016.

For more details, go to: http://www.tga.gov.au/prescription-medicines-new-or-extended-uses-registered-medicines

 

Michael Wonder

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Michael Wonder