Sedor Pharmaceuticals, LLC: Sesquient

Please refer to your new drug application (NDA) dated and received May 22, 2018, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for Sesquient (fosphenytoin sodium) injection, 100 mg and 500 mg phenytoin sodium equivalents/ml.

Provide data demonstrating that the actions taken will prevent reoccurrence of particles in the drug product.

Your original application submitted May 22, 2018, relied on, in part, FDA's finding of safety and effectiveness for Parke Davis's NDA 020450 for Cerebyx (fosphenytoin sodium) injection.

To address this deficiency, the cover letter for your June 28, 2019, resubmission (RS) to our CR letter stated "For additional Captisol safety data, Sedor is also relying on the Agency's previous findings of safety for the following RLDs:

2. Your June 28, 2019, resubmission included Paragraph IV certifications with respect to the following U.S. Patents Nos.

Act for Sesquient (fosphenytoin sodium) injection, 100 mg and 500 mg phenytoin sodium equivalents/ml.

1. The proposed prescribing information indicates that the drug product can be diluted in either 5% dextrose or 0.9% saline to a concentration ranging from 1.5 mg phenytoin equivalents (PE)/mL to 25 mg PE/mL.

Provide data demonstrating that the drug product is stable in 5% dextrose.

2. Inaresponse to an information request dated November 16, 2018, you indicated that the assay, identification, and impurity method was originally validated in 2007. Additionally, you stated that the method was not validated specifically for the related substances.

Agency's regulations at 21 CFR 314.54. The regulatory requirements for a 505(b)(2) application apply to each listed drug on which the application relies and include but are not limited to: 1) providing an adequate bridge to establish that reliance on the listed drug is scientifically appropriate; and 2) providing an appropriate patent certification or statement.

Upon resubmission of your application, submit draft carton and container labeling revised as follows:

July 6, 2017, our response to Question 9 of the Type C Meeting dated June 3, 2016, and our response to Question | of the Pre-IND meeting dated September 20, 2006, the proposed product does not comply with the USP Monograph for Fosphenytoin Sodium Injection.