April 2016 NCE registrations - TGA

2 May 2016 - The TGA registered two new chemical entities (medicines) and two new blood products in April 2016.

The new medicines are:

  • Cobimetinib hemifumarate (Cotellic) - use in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation
  • Avanafil (Spedra) - treatment of erectile dysfunction in adult males

The new blood products are:

  • Octocog alfa (Kovalty) - treatment and prophylaxis of bleeding in patients of all ages with haemophilia A (congenital factor VIII deficiency)
  • Susoctocog alfa (Obizur) - treatment of bleeding episodes in adults with acquired haemophilia A

For more details, go to: http://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia

Michael Wonder

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Michael Wonder