Drugs / Hydrocortisone Butyrate
Hydrocortisone Butyrate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LOCOID LIPOCREAM | — | 2009-10-19 | fda.gov ↗ |
| Approved | US (FDA) | LOCOID | — | 1982-03-31 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02973776 | Dec 2016 → Feb 2017 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00640614 | Apr 2008 → Aug 2009 | contact dermatitis | Allerderm | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02959580 | Jan 2017 → Sep 2020 | granulomatous mastitis | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT03758365 Comparator | Nov 2018 | vascular disorder | MC2 Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03676933 Background | Oct 2015 → Apr 2016 | atopic eczema | DS Biopharma | Completed | No outcome recorded |
| Phase 2 | NCT00801957 Comparator | Mar 2003 → Nov 2004 | atopic eczema | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT03766997 Background | Feb 2019 → Jan 2021 | granulomatous mastitis | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03539601 Comparator | Apr 2018 → Dec 2020 | atopic eczema | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02116608 Comparator | Sep 2014 → Sep 2019 | tracheal disorder | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT00693693 Comparator | Nov 2006 → Sep 2008 | atopic eczema | Wake Forest University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2018-08-21 | Lupin Limited | Regulatory Lupin receives FDA approval for generic Hydrocortisone Butyrate Lotion, 0.1% lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin announced that it has received final approval for its Hydrocortisone Butyrate Lotion, 0.1% from the United States Food and Drug Administration (FDA) to market a generic version of PreCision Dermatology, Inc.’s (PreCision) Locoid Lotion, 0.1%. |
| 2018-02-11 | Lupin Limited | Regulatory Lupin receives tentative FDA approval for generic Locoid® Lotion lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin announced that it has received tentative approval for its Hydrocortisone Butyrate Lotion, 0.1% from the United States Food and Drug Administration (FDA) to market a generic version of Precision Dermatology, Inc.’s Locoid® Lotion, 0.1%. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-08-21 | Lupin Limited | Lupin receives FDA approval for generic Hydrocortisone Butyrate Lotion, 0.1% lupin.com ↗ |
| 2018-02-11 | Lupin Limited | Lupin receives tentative FDA approval for generic Locoid® Lotion lupin.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | hydrocortisone butyrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00801957 ↗ |
| Known as | Hydrocortisone-17-Butyrate | “Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-Butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse...” NCT00640614 ↗ |
| Known as | Locoid | “Locoid® hydrocortisone-17-butyrate 0.1% ointment” NCT02973776 ↗ |
| Route | Topical | “topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis” NCT00693693 ↗ |