Drugs / fluticasone propionate/salmeterol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | asthma | 2016-06-28 | “The NDAs for fluticasone propionate/salmeterol RespiClick and fluticasone propionate RespiClick have been accepted by the FDA for standard review” tevapharm.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02680561 | Apr → Jun 2016 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2017-01-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of Two New RespiClick® Maintenance Inhalers for the Treatment of Asthma tevapharm.com ↗ |
| 2016-06-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Acceptance of New Drug Applications for Fluticasone Propionate/Salmeterol and Fluticasone Propionate RespiClick® Inhalers tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug applications (NDAs) for two products for adolescent and adult patients with asthma. |
| 2015-11-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Reports Positive Top-Line Results from Phase III Trials Evaluating Fluticasone Propionate/Salmeterol and Fluticasone Propionate Multidose Dry Powder Inhalers (MDPIs) in Patients with Asthma tevapharm.com ↗
Top-line data showed that the studies met their primary endpoints. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-01-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Approval of Two New RespiClick® Maintenance Inhalers for the Treatment of Asthma tevapharm.com ↗ |
| 2016-06-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Acceptance of New Drug Applications for Fluticasone Propionate/Salmeterol and Fluticasone Propionate RespiClick® Inhalers tevapharm.com ↗ |
| 2015-11-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Reports Positive Top-Line Results from Phase III Trials Evaluating Fluticasone Propionate/Salmeterol and Fluticasone Propionate Multidose Dry Powder Inhalers (MDPIs) in Patients with Asthma tevapharm.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fluticasone propionate/salmeterol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02680561 ↗ |
| Route | Inhaled | “single oral inhalation dose” NCT02680561 ↗ |