Other Ophthalmic Surgery Organ Transplantation Orthopaedics Other Osteoarthritis Osteoporosis Otitis Otorhino. Doxil has been granted orphan drug status for ovarian cancer, which provides for seven years of marketing exclusivity. Refractory is defined as a patient having progressive disease while on treatment, or within six months of completing treatment. The December 1998 submission was supported by two Phase II clinical trials. The FDA has agreed that there is an unmet medical need for patients addressed by this sNDA, and as such, the agency would evaluate the supplemental application under accelerated approval regulations.
Applications targeted for accelerated approval typically receive a priority review.
The FDA goal for review and action on priority review applications is six months from the date of submission. Any question regarding a medical diagnosis, treatment, referral, drug availability or pricing should be directed to either a licensed physician or to the product's manufacturer. All rights reserved.