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FDA Reports Full Acceptance of Animal Antibiotic Plan

FDA Reports Full Acceptance of Animal Antibiotic Plan

26 pharmaceutical companies agree to comply with FDA's guidance 213

Six months into its plan to phase out "medically important" antimicrobials in food animals and phase in veterinary oversight of any therapeutic use of the products, the Food and Drug Administration said Monday that all companies producing affected antimicrobials have agreed to comply.

The plan, called Guidance for Industry #213, was released at the end of 2013 and specified that companies had until December 2016 to comply.

FDA, in its first six-month progress report, summarized current and pending actions taken by sponsors to align with the guidance.

Related: Animal Pharmaceutical Companies Commit To FDA's Antibiotic Guidance

26 pharmaceutical companies agree to comply with FDA's animal antimicrobial guidance 213

As of June 30, 2014, FDA said, the last sponsor, Pharmaq AS, has agreed in writing to engage in the judicious use strategy, and has consented to allow FDA to publicly acknowledge its participation.

With this addition, all 26 sponsors of 283 affected applications have now confirmed in writing their intent to engage with FDA as defined in GFI #213 and have given FDA consent to identify them as participants.

The report also said that there have been two published label changes, one to withdraw a production claim and one to change a product’s marketing status from over-the-counter to available by prescription only.

Related: FDA Touts Acceptance of Animal Antibiotic Plan, But Groups Uncertain

One additional drug label change is currently pending to move from over-the-counter marketing status to prescription status.

In addition, 31 approvals for affected products have been withdrawn to date, and there are no drug approval withdrawals currently pending.

A chart of affected products will be continuously updated with product label changes as a result of guidance 213, FDA said.

Read more: FDA Blog: An Update on FDA’s Guidance 213

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