Drugs

FDA Denies Zydus Mephyton Petition

FDA has denied three requests included in a 5/6 citizen petition submitted on behalf of Zydus Pharmaceuticals relating to its Mephyton (phytonadione) vitamin K1 tablets. The company had asked that the agency:

require that manufacturers of generic phytonadione tablets establish sameness with the reference-listed-drug (RLD) Mephyton by (1) providing data for each isomer in the phytonadione drug substance by way of identification and quantification through validated tests with appropriate limits demonstrating comparable isomeric purity to the RLD and (2) control the level of Z isomers in the drug substance to be comparable to the RLD;
refrain from approving any ANDA absent such a showing; and
downgrade the therapeutic equivalence (TE) code of any generic drug product currently listed as AB in the Orange Book to BX unless and until sufficient data had been provided to FDA to demonstrate the comparable isomeric purity of the active ingredient to that of the RLD.

The agency response letter denies the request to downgrade the TE code because the agency has not made a decision to change the code for any ANDA referencing Mephyton. The letter says FDA uses a variety of sources to monitor the efficacy and safety of all drug products, and says the agency “will continue to consider the information the company submitted in its petition and exhibits, as well as any other relevant information, and to take appropriate action regarding the TE code of an approved ANDA if and when FDA decides the circumstances warrant it.”

On the other two requests, the letter says FDA has not made a decision on any application referencing Myphyton and thus is denying the petition without comment on whether it will take the action requested.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome