Fera Pharmaceuticals, LLC: Avaclyr

Please refer to your New Drug Application (NDA) dated and received, May 31, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for Avaclyr (acyclovir ophthalmic ointment) 3%.

June 24, 2016, informing you that we completed our review of this application.

Avaclyr (acyclovir ophthalmic ointment) 3.0%.

An application submitted under 505(b)(2) needs to provide a scientific "bridge" between the proposed product and the product used in the clinical studies submitted to the application.

The information submitted to your application on July 24, 2013, March 12 and 25, 2014, is insufficient to establish a scientific "bridge" between the proposed product and the product used in the published clinical trials which are needed for the determination of the safety and efficacy of acyclovir ophthalmic ointment in the proposed indication of acute herpetic keratitis (dendritic ulcers).

3% be compared with 3 lots (if available) of the Zovirax acyclovir ophthalmic ointment 3% product that may serve as the nominal RLD, and that the variation for measured product quality attributes fall within the variability observed for the nominal RLD.

2. It is known that formulations of White Petrolatum, USP can exhibit non-Newtonian (shear-thinning) behavior (e.g., see Park & Song (2010) Rheological evaluation of petroleum jelly as a base material in ointment and cream formulations with respect to rubbing onto the human body, Korea-Australia Rheology Journal 22(4) 279-289).

To support a scientific bridge, we recommend that the comparative particle size analysis be performed as a 3-tier analysis, reporting the D10, D50 and D90 particle sizes, compared for the nominal RLD and Fera's acyclovir ophthalmic ointment 3%.

8. Provide English translations of current approved foreign labeling not previously submitted.