Prescription medicines: new or extended uses approved by the TGA (May 2016)

19 May 2016 - The TGA has approved new indications for four medicines so far this month.

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 four medicines are:

  • Tenofovir disoproxil fumarate with emtricitabine (Truvada) - Pre-exposure prophylaxis (PrEP)
  • Secukinumab (Cosentyx) - psoriatic arthritis and ankylosing spondylitis
  • Perampanel hemisequihydrate (Fycompa) - primary generalised tonic-clonic seizures
  • Ulipristal acetate (Esmya) - uterine fibroids

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

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Outcome , Medicine , Australia