- Under the Europe's Decentralized Procedure, Allergan's (NYSE:AGN) BELKYRA (deoxycholic acid) receives a positive opinion from the Swedish Medical Products Agency for the use of the product to treat moderate-to-severe fullness associated with submental fat (double chin). Approval and subsequent market launch should happen later this year or early 2017.
- The Decentralized Procedure allows for product approval in one country to apply to others in the EU under mutual recognition. In this case, Sweden is the Reference Member State. The other pathway, the centralized procedure, goes through the European Medicines Agency (new drugs and biologics for human use).