Fresenius Kabi wants Wockhardt to amend Zosyn approval BSE filing

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Food and drug administration

Fresenius Kabi wants Wockhardt to change a BSE filing it says does not accurately reflect its role in the production of a Zosyn generic recently approved in the US.

Wockhardt announced US approval for its version of Pfizer's combination antibiotic Zosyn (piperacillin and tazobactan) in a Bombay Stock Exchange Filing (BSE) on March 21​.

The Mumbai firm said Wockhardt Bio AG filed the abbreviated new drug application (ANDA) “in collaboration with Fresinius Kabi (sic), Italy (FKAI) where the product development was completed​.”

It also said: “The ANDA will be manufactured commercially at FKAI, Mitim, Italy​.”

The US Food and Drug Administration (FDA) confirmed the ANDA has been approved, telling us “the Orange Book​ shows multiple approved versions of piperacillin and tazobactam from Wockhardt​.”

We covered the announcement yesterday​.

Wrong references

However, while the approval information is accurate, other parts of the BSE filing are confusing and need to be changed according to a Fesenius Kabi spokesman.

He told us “there has been quite a confusion in the message.​..we definitely want to amend the initial communication made by Wockhardt since it contains wrong references to Fresenius Kabi companies.​”

FKAI’s role was to supply the active pharmaceutical ingredient (API) the spokesman explained, adding that Wockhardt Bio AG developed and filed the ANDA dossier.

The spokesman also told us commercial manufacture will be carried out by Recipharm’s Italian unit Mitim​, adding that “FKAI is handling Mitim/Recipharm on behalf of Wockhardt and is therefore acting as its commercial provider for the drug products​.”

He added that Fresenius Kabi Italy “had no participation in it [Zosyn production] and will not have any in the future” ​going on to say “we are looking forward to receiving the amended communication…reflecting the real set up of the concerned business​.”

Wockhardt did not respond to a request for comment.

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