Alkermes
Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IrelandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
- Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 13, 2 entities
- Drug applications: 7
- Drug recalls: 4
- Complete response letters: 1
- OPDP letters: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Alkermes and its 1 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Nov 13, 2020 | Complete response letter, NDA 213378/Original 1, NDA 213378/Original 2Approved | Complete response letters |
| Dec 2, 2019 | Warning letter: VIVITROLOffice of Prescription Drug Promotion | OPDP letters |
| Aug 8, 2019 | Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) OnClass II · Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch need | Drug recalls |
Subsidiaries and Divisions
1 firms in the Alkermes group, most records first- Alkermes Gainesville2 records
Names and Identifiers
- Appears as
- Website
- alkermes.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built