FDA Approves Triple Combination Therapy for Cystic Fibrosis
Drug able to treat 18,000 people will cost over $300k per year.
Minocycline Topical Foam 4% Approved by FDA for Acne Vulgaris
Available for prescribing starting January 2020
FDA Approves Baloxavir Marboxil for High-Risk Flu Patients
First approved in 2018 for patients 12 years of age and older.
Cetirizine IV Approved for Pediatric Acute Urticaria
Originally approved in 1995 for use in adults only.
FDA Approves Asenapine for Schizophrenia
Administered via a once-daily transdermal patch.
5 New Diabetes Technologies and Treatments
Noteworthy diabetes management products and updates making waves this year.
FDA Warns of Cough Syrup Contamination
Consumers should stop use and report any adverse events.
Dexcom G6 Continuous Glucose Monitor Approved by FDA
New CGM eliminates fingersticks, introduces new data presentation.
Rare Light Sensitivity Disorder Drug Approved by FDA
Afamelanotide released through subcutaneous implant.
Wilate Approved for Hemophilia A Treatment
Also indciated to control bleeding and perioperative management.
Brolucizumab-dbll Approved by FDA for Wet AMD
Injection for leading cause of severe vision loss and legal blindness.
FDA Approves Trifarotene Cream for Acne Treatment
First new treatment of its kind in over 20 years.
FDA Approves Second HIV PrEP Treatment
Currently only approved for men and transgender women; future trials expected.
Rituximab Gains First Pediatric Approval
For granulomatosis with microscopic polyangiitis in children.
FDA Approves Canagliflozin Indication Expansion
Now approved for risk reductions in patients with type 2 diabetes mellitus.
Investigational Guillain-Barré Syndrome Treatment Granted FDA Fast Track Designation
Monoclonal antibody for autoimmune and neurodegenerative disorders.
New Semaglutide Dosage Forms Approved by FDA
Now approved in 7mg and 14 mg tablets.
Potential Treatment for Traumatic Brain Injury Receives Regenerative Advanced Therapy Designation
Derived from cultured adult bone marrow-derived mesenchymal stem cells that have undergone temporary genetic modification.
Obinutuzumab Receives Breakthrough Therapy Designation from FDA
Monoclonal antibody shows potential for lupus nephritis treatment.
FDA Approves First Drug Under Project Orbis
Combination therapy for advance endometrial carcinoma.
Tenapanor Approved for Adults with IBS-C
NHE3 inhibitor administered as 50 mg oral tablets.
FDA Warns of NDMA Traces in Ranitidine Products
Patients are still allowed to take medicines as prescribed.
FDA Grants Tepotinib Breakthrough Therapy Designation
Investigational oral MET kinase inhibitor from Merck.
FDA Approves New Generic for Rare HT-1 Disorder
Oral supplements for metabolic disorder.
Nintedanib Approved for Rare Lung Disease
Oral kinase inhibitor for SSc-ILD.
Decitabine and Fosaprepitant Generics Approved by FDA
First generic specialty injections approved for Novadoz Pharmaceuticals.
Depression Drugs Market to Generate $5,000 Million
Though decreasing, initiatives and awareness will generate more revenue.
Safety Warning Issued for Hepatitis C Drugs
Rare instances of worsening liver function reported to FDA.
Drug Disposal Bins Coming to California
Grant-funded program to bring more opportunities for safe disposal.
EPA Final Rule: What Community Pharmacists Need to Know