Drugs / OTX-101
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | dry eye syndrome | 2017-12-27 | “announces that the US FDA has accepted a New Drug Application (NDA), filed by its wholly owned subsidiary, for OTX-101” sunpharma.com ↗ “reporting acceptance of N DA filing for OTX-101 by the US FDA.” sunpharma.com ↗ “Sun Pharma Announces US FDA Acceptance of NDA for OTX-101” sunpharma.com ↗ “the US FDA accepted our NDA for OTX-101 in December 2017.” sunpharma.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT02254265 | Sep 2014 → May 2015 | dry eye syndrome | Sun Pharmaceutical Industries, Inc. | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT02845674 | Jul 2016 → Aug 2017 | dry eye syndrome | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2017-12-27 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Announces US FDA Acceptance of NDA for OTX-101 sunpharma.com ↗ |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2017-12-27 | Sun Pharmaceutical Industries, Inc. | Sun Pharma Announces US FDA Acceptance of NDA for OTX-101 sunpharma.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OTX-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02845674 ↗ |