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# Par Wants Petition Denial Partially Reversed
- URL: https://www.fdaweb.com/par-wants-petition-denial-partially-reversed/
- Published: 2017-03-09T12:00:00.000Z
- Updated: 2026-09-14T22:10:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138169

Par is asking FDA to modify its denial of a company 8/1/16 petition that asked the agency to take specific steps involving ANDAs for an epinephrine injection 1mg/mL product in a 1 mL vial, ampule, pre-filled syringe, or similar parenteral administration modality. Specifically, the Par petition asked the agency to: 

- refrain from approving any ANDA submitted under Section 505(j) of the FDCA for an epinephrine injection 1mg/mL product in a 1 mL vial, ampule, pre-filled syringe or similar parenteral administration modality, unless such product contains the same inactive ingredient composition as Adrenalin (epinephrine injection) 1mg/mL reformulated pursuant to an NDA supplement; or
- in the alternative, require the proposed generic product to have the same or lower levels of impurities as reformulated Adrenalin, as demonstrated through testing commensurate with the postmarket testing required by FDA and performed by Par following the agency’s review of Par’s initial NDA for Adrenalin.

  
In its [request](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-1392-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) for a decision modification, Par says that FDA denied its initial petition 12/23/16\. Addressing the second part of the Par request, the new petition says, FDA said that a generic product **(1)** need not have impurity specifications identical to those of the reference-listed drug, as variables such as differences in manufacturing processes or ingredient sources may affect levels of impurities and appropriate test and acceptance criteria; **(2)** that the potential safety or efficacy impacts of any differences in impurity profiles would be assessed on a case-by-case basis; **(3)** that Par had agreed to conduct its postmarket testing and had not been required to do so by FDA; and **(4)** that principles of fairness and equity did not obligate FDA to reject ANDAs for generic products that do not have the same or lower levels of impurities as reformulated Adrenalin as demonstrated through testing commensurate with Par’s postmarket testing.

“Certain conclusions reached by FDA in its response to the petition were improper.” Par says, “as they were based on erroneous assumptions and/or a misunderstanding of the chemistry of the products at issue and therefore of the basis for the requests set forth in the petition. In particular, FDA’s rote adherence to the general policy that all ANDAs require a case-by-case review to determine acceptable impurity levels belies the scientific realities with respect to Adrenalin.”

Par also says it believes that the administrative record for its NDA for Adrenalin “unequivocally reflects that FDA treated the postmarket testing to be conducted by Par as a requirement. Fairness and equity considerations dictate that ANDA applicants whose proposed generic products have higher levels of impurities than reformulated Adrenalin be required to conduct similar postmarket studies as required of Par.”

After detailing its objections to FDA’s conclusions and explanations, Par asks that the agency modify its 12/23/16 decision and require any generic epinephrine injection 1mg/mL product in a 1 mL vial, ampule, pre-filled syringe, or similar parenteral administration modality to have the same or lower levels of impurities as reformulated Adrenalin, as demonstrated through the postmarket testing required by FDA and performed by Par.