Initial Product(s)

Initial Product(s). Up to 1500 USP units per vial of recombinant human PH20 hyaluronidase as the active pharmaceutical ingredient in (i) any liquid injectable formulation, and/or (ii) any lyophilized formulation, which shall include the Initial Drug, in each case for the DESI Review indication of "enhancing the dispersion and absorption of other injected drugs" (cf. Federal Register, supra). Initial Product(s) shall also encompass any of the following improvements to the Initial Drug: line extensions, packaging,... labeling, change of excipient, minor alterations of the Initial Drug itself (such as variations in the structure of the active compound that do not substantially alter its properties (i.e. as would not require a new IND and/or a Supplemental New Drug Application (NDA)), and Initial Drug produced by newly developed manufacturing methods View More