APP Pharmaceuticals Receives Final Approval for Nausea Drug

APP Pharmaceuticals has received final approval from the FDA for its ANDA to market a generic version of Roche’s Kytril in 1-mg/mL, 1-mL single-dose and 1-mg/mL, 4-mL multiple-dose vials.

The company already markets generic Kytril (granisetron HCl) in 0.1-mg/mL, 1-mL single-dose vials and will start distributing the other vials immediately, APP said.

Kytril is indicated for preventing nausea and vomiting associated with cancer chemotherapy and radiation.

The FDA previously approved generic Kytril ANDAs submitted by Apotex, Barr Pharmaceuticals, Baxter Healthcare, Roxane Laboratories and Watson Pharmaceuticals.

According to IMS data, branded sales of these two dosage forms of granisetron were approximately $72.2 million last year.