FDA Events for AptarGroup (ATR)
This section highlights FDA-related milestones and regulatory updates for drugs developed by AptarGroup (ATR).
Over the past two years, AptarGroup has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SmartTrack™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SmartTrack™ - FDA Regulatory Timeline and Events
SmartTrack™ is a drug developed by AptarGroup for the following indication: In-Vitro-in-Silico Platform for Pressurized Metered-Dose Inhalers.
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:
- SmartTrack™
- Announced Date:
- April 16, 2025
- Indication:
- In-Vitro-in-Silico Platform for Pressurized Metered-Dose Inhalers
Announcement
AptarGroup, Inc. announces the commencement of a clinical study to validate its proprietary SmartTrack™ platform.
AI Summary
AptarGroup, Inc. has announced the start of a clinical study to validate its SmartTrack™ platform, developed by its drug services company, Nanopharm. This study aims to show that SmartTrack™ can accurately predict clinical outcomes, potentially reducing the need for full clinical studies during the approval of generic drug products. The platform could serve as an in-vitro-in-silico alternative to traditional comparative clinical endpoint studies, addressing a key challenge for pharmaceutical companies and regulators.
Starting in Q2 2025, the study will involve radio-labelling three commercially available pressurized metered-dose inhaler products to image regional lung deposition. These results will then be compared with predictions from computer simulations and pharmacokinetic data. If validated, SmartTrack™ could accelerate the approval process and broaden patient access to generic medicines.
Read Announcement
AptarGroup FDA Events - Frequently Asked Questions
As of now, AptarGroup (ATR) has not received any FDA approvals for its therapy in the last two years.
In the past two years, AptarGroup (ATR) has reported FDA regulatory activity for SmartTrack™.
The most recent FDA-related event for AptarGroup occurred on April 16, 2025, involving SmartTrack™. The update was categorized as "Study Initiation," with the company reporting: "AptarGroup, Inc. announces the commencement of a clinical study to validate its proprietary SmartTrack™ platform."
Currently, AptarGroup has one therapy (SmartTrack™) targeting the following condition: In-Vitro-in-Silico Platform for Pressurized Metered-Dose Inhalers.
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 (NYSE:ATR) was last updated on 7/10/2025 by MarketBeat.com Staff
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