Original New Drug Application Approvals by US FDA (01 - 15 February 2021)
16 Feb 2021
New drug applications approved by US FDA as of 01-15 February 2021 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
POSIMIR
POSIMIR
- Active Ingredient(s): Bupivacaine
- Strength: 132MG/ML
- Dosage Form(s) / Route(s): Injectable; Injection
- Company: Durect Corp
- Approval Date: 01 Feb 2021
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.
- Approved Label: 01 Feb 2021 (PDF)
- Active Ingredient(s): Tepotinib Hydrochloride
- Strength: 225MG
- Dosage Form(s) / Route(s): Tablet; Oral
- Company: EMD Serono Inc
- Approval Date: 03 Feb 2021
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
- Approved Label: 03 Feb 2021 (PDF)
- Active Ingredient(s): Umbralisib Tosylate
- Strength: 200MG
- Dosage Form(s) / Route(s): Tablet; Oral
- Company: TG Therapeutics Inc
- Approval Date: 05 Feb 2021
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of adult patients
with:
- Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen.
- Relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
- Approved Label: 05 Feb 2021 (PDF)