Sentence examples for a supplemental indication from inspiring English sources

Furthermore, despite the limited data on which many supplemental indication approvals are based, legislation that recently passed the US House of Representatives threatens to further diminish the level of evidence needed to obtain a supplemental indication for an approved prescription drug.

However, we found medical reviews for only 20% of all supplemental indication approvals during our study time period, with such information available for one of 26 supplemental indication approvals from 2013 and for none of 40 from 2014.

Instead, we assessed the supporting clinical evidence for all supplemental indications at the time of approval by accessing the earliest FDA drug label in the Drugs@FDA database that mentioned the newly approved use.

We excluded duplicates, counting only once an approval of the same supplemental indication relating to multiple formulations of the same active ingredient.

(RTF 10 kb) Additional file 2: Appendix A: Supplemental Tables.

2 Such statements are also needed for supplemental indication approvals.

New indications constituted almost half (n=137; 46%) of supplemental indication approvals, and nearly all supplemental indications that specifically expanded the patient population of a previously approved use (n=65) related to pediatric patients (61/65; 94%).

We found that 80% of FDA medical reviews for supplemental indication approvals were not accessible.

For each supplemental indication approval, we determined its primary therapeutic area by consensus.

We were left with 295 supplemental indication approvals relating to 164 unique drugs.

*Total n=294 supplemental indications and n=201 original indications for 164 novel therapeutic agents; no study comparator information for trials supporting supplemental indication approval for celecoxib (Celebrex) in July 2005 or original indication approval for fluvastatin (Lescol, Novartis, Basel, Switzerland) in December 1993.