> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Par Wants Adrenalin ANDA Limits
- URL: https://www.fdaweb.com/par-wants-adrenalin-anda-limits/
- Published: 2016-08-03T12:00:00.000Z
- Updated: 2026-09-14T21:21:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136387

Par Sterile Products is asking FDA not to approve any ANDA for an epinephrine injection 1 mg/mL product in a 1 mL vial, ampule, pre-filled syringe or similar parenteral administration modality unless the generic product contains the same inactive composition as would the reformulated Par Adrenalin (epinephrine injection). An 8/1 [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-2376-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) says that Par has submitted a sNDA for the reformulated Adrenalin that has not yet been approved. An alternative solution, Par says, would be for FDA to require the generic product to have the same or lower levels of impurities as would the proposed reformulated Adrenalin as demonstrated through testing commensurate with the testing performed by Par in connection with the post-market commitments imposed by FDA following its review of the company’s initial NDA for Adrenalin.

The petition says that the Adrenalin NDA was approved 12/7/12 indicated for intramuscular or subcutaneous use for emergency treatment of allergic reactions, including anaphylaxis. During its review of the NDA, the agency expressed concern about the level of impurities found in the product, the petition says, and Par tightened the acceptance criteria for impurities and agreed to post-marketing commitments to investigate the cause for the levels of certain impurities and to take necessary measures to reduce the levels. Par says its January sNDA seeks approval for, among other things, a change in formulation to provide a more stable Adrenalin product with lower impurity levels.

“The new Adrenalin formulation … has been shown by the data provided … to have improved stability and greater purity as compared to the formulation of Adrenalin initially approved…,” the petition says. “A failure to duplicate the nature and quantity of ingredients contained in proposed reformulated Adrenalin would have a negative impact on the impurity profile of the product.”