Innocoll Pharmaceuticals: bupivacaine hydrochloride collagen-matrix implants

Cosmetic Act (FDCA), for bupivacaine hydrochloride collagen-matrix implants, 100 mg per implant.

Specifically, although your extraction study submitted September 20, 2018, was capable of detecting compounds at the requested safety concern threshold of tjmcg/day, you did not identify many of the compounds detected above this safety threshold.

Provide a toxicological risk assessment for any leachable compound present in the drug product at tameg/day or greater.

2018. The final determination of the indication for your drug product will be made at the time of approval, however, it is likely to include only the surgical population in which the drug product was tested and demonstrated to be safe and effective.

Note that resubmission goals will not apply to any resubmission of this application.