Endo International plc announced that the U.S. Food and Drug Administration (FDA) has accepted for review the original Biologics License Application (BLA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks. The Prescription Drug User Fee Act (PDUFA), or target action date for the BLA, has been set for July 6, 2020. Cellulite is a localized alteration in the contour of the skin that has been reported in 85% to 98% of post-pubertal females and affects women of all races and ethnicities. The primary cause of the condition is a thickening of the collagen septae that attach the skin to the underlying fascia layers with additional contributing protrusions of subcutaneous fat. The septae tether the skin, which causes the surface dimpling characteristic of cellulite. Cellulite clinically presents on the buttocks, thighs, lower abdomen and arms. It is known that cellulite is different from generalized obesity. In generalized obesity, adipocytes undergo hypertrophy and hyperplasia that are not limited to the pelvis, thighs, and abdomen. In areas of cellulite, characteristic large, metabolically stable adipocytes have physiologic and biochemical properties that differ from adipose tissue located elsewhere. Weight gain makes cellulite more noticeable, but it may be present even in thin subjects. Genetics may also play a role, since cellulite tends to run in families. Despite multiple therapeutic approaches for the attempted treatment of patients with cellulite, there are currently no FDA-approved injectable treatments on the market.