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Background and Importance FDA approved Prescription Digital Therapeutics (PDTx) presents an innovative category of professionally endorsed software designed for treatment of various medical disorders. App only PDTx provides a distinctive opportunity to deliver approved therapies, via mobile phones, either as a standalone or alongside the traditional pharmaceuticals. For pharmacists, this shift in disease management necessitates moving beyond traditional pharmacotherapy management and requires new competencies in patient counselling for digital products.Aim and Objectives This review aims to identify and categorise FDA approved, PDTx that are app based, and are exclusively developed for management of health conditions. Special focus is given on the therapeutic applications, clinical benefits, reimbursement pathways, and incorporation of PDTx in the domain of patient care. In addition to that, the critical role of hospital/community pharmacists in the initiation and patient education for these novel digital therapies will be outlined.Material and Methods A targeted search for FDA-cleared app based PDTx was performed to identify PDTx approved from 2015 to 2025. The search was conducted using PubMed, ClinicalTrials.gov, FDA databases and manufacturers websites. The obtained data related to therapeutic targets, treatment modality, duration, and contraindications was analysed. The extracted data was structured to support pharmacy practice and highlight the pharmacy-led monitoring requirements.Results The review identified nine key FDA approved app based PDTx that included reSET (Substance use disorder), reSET-O (Opioid use disorder), Somryst (Chronic insomnia), Rejoyn (Major depressive disorder), CT-132 (Episodic migraine), DaylightRx (Generalised anxiety disorder), Mahana IBS (Irritable bowel syndrome), Regulora (Irritable bowel syndrome), AspyreRx™ (Type 2 diabetes). Their main therapeutic modality is based on cognitive behavioural therapy, brain-training exercises, and gut-directed hypnotherapy. Since App-based PDTx are not typical pharmaceutical agents; they may create complexities related to pharmacist consultations and related patient care.Conclusion and Relevance FDA approved app based PDTx propose an effective, patient-centric alternative solution to traditional healthcare. However, their successful adoption into practice requires a clear understanding and education for patients, physicians and pharmacists.References and/or Acknowledgements 1. Watson A, Chapman R, Shafai G, Maricich YA. FDA regulations and prescription digital therapeutics: evolving with the technologies they regulate. Front. Digit. Health 2023;5:1086219.2. Docherty JP, Colbert BM. The evolution of psychotherapy: from Freud to prescription digital therapeutics. Front. Psychiatry 2024;15:1477543.Conflict of Interest No conflict of interest