Available in the UK. Price for Ngenla 24mg/1.2ml solution for injection pre-filled pen x 1 = £189.60; 60mg/1.2ml solution for injection pre-filled pen x 1 = £474.00 .
Granted orphan drug status in UK .
Approved in the UK for the "treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone." .
Approved in the EU 
US FDA has declined approval and issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon for the treatment of growth hormone deficiency (GHD) in paediatric patients. Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward. The decision was unexpected considering Ngenla has approval in Canada, Japan and Australia and a positive opinion from the EMA .
Recommended for EU approval by CHMP “for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone.” Ngenla will be available as 24 mg/1.2 ml and 60 mg/1.2 ml solutions for injection .
FDA decision delayed with PUFDA date delayed till January 22 .
EMA has accepted for review the MAA for somatrogon for once-weekly treatment of pediatric patients with growth hormone deficiency. Pfizer expects a decision from the EC in 2022 .
Pfizer have exclusive licence to commercialise somatrogon .
Filed in US, with decision anticipated by October 21 .
Company now OPKO Health .
Has orphan drug status in EU & US