The Avycaz (ceftazidime-avibactam) shortage was to the US Food and Drug Administration (FDA) last week by Allergan’s subsidiary Cerexa Inc.
The firm cited a “shortage of active ingredient” as the reason and said supplies would be limited until February 2017.
According to a document on Allergan’s website UK drug manufacturer GSK makes the combination drug at a facility in Verona, Italy.
In a prepared statement GSK said: “As soon as we realised there was an issue with the supply we contacted Allergan we have been in regular communication since. We are working hard to resolve the issue as soon as possible.”
A GSK spokeswoman confirmed the firm makes the API avibactam for Avycaz, but said the unspecified issue occured at a primary manufacturing site in the UK rather than the secondary production site in Verona.
Avycaz – which was approved in the US last June -is used to treat complicated intra-abdominal Infections (cIAI) and urinary Tract Infections (cUTI) caused by bacteria resistant to other antibiotics.
The product generated revenue of $13.7m (€12.1m) in the US in the second quarter according to financials released by Allergan last week.
Allergan did not respond to a request for comment.
Avycaz was developed by Actavis, now Allergan, in collaboration with AstraZeneca.
AstraZeneca has rights to sell it in Europe where it was approved in June under the brand name Zavicefta.