FDA Events for Antares Pharma (ATRS)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Antares Pharma (ATRS).
Over the past two years, Antares Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TLANDO. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TLANDO - FDA Regulatory Timeline and Events
TLANDO is a drug developed by Antares Pharma for the following indication: Oral testosterone.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TLANDO
- Announced Date:
- June 9, 2025
- Indication:
- Oral testosterone
Announcement
Lipocine Inc. announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO® in Canada.
AI Summary
Lipocine Inc. announced that its licensing partner, Verity Pharma, has filed a New Drug Submission (NDS) for TLANDO® in Canada. This important filing marks the next step in making TLANDO® available in the Canadian market. The company sees a strong opportunity in Canada, where over 700,000 testosterone replacement therapy prescriptions are written annually. TLANDO® is already approved by the US Food and Drug Administration (FDA) as the first and only oral testosterone replacement therapy that does not require dose titration, and if approved in Canada, it could capture a significant share of this growing market.
Mahesh Patel, CEO of Lipocine, expressed confidence that the introduction of this unique oral TRT option will drive considerable market gains and offer an attractive treatment alternative for patients in Canada.
Read Announcement
Antares Pharma FDA Events - Frequently Asked Questions
As of now, Antares Pharma (ATRS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Antares Pharma (ATRS) has reported FDA regulatory activity for TLANDO.
The most recent FDA-related event for Antares Pharma occurred on June 9, 2025, involving TLANDO. The update was categorized as "Provided Update," with the company reporting: "Lipocine Inc. announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO® in Canada."
Currently, Antares Pharma has one therapy (TLANDO) targeting the following condition: Oral testosterone.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ATRS) was last updated on 7/10/2025 by MarketBeat.com Staff
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