FDA Bursts

In cooperation with the Food and Drug Administration (FDA), and as a service to our members, we will periodically distribute information about newly approved therapies or significant changes to approved therapies. This helps FDA to inform professionals in patient care arena of recent approvals in a timely manner. Included in the email from the FDA is a link to the product label, which will provide the relevant clinical pharmacology information on the indication, contraindications, dosing, and safety. In sending this information, we do not endorse any product or therapy and do not take any position on the safety or efficacy of the product or therapy described.

FDA Approves SCENESSE (Afamelanotide) Implant to Increase Pain Free Light Exposure in Adult Patients with a History of Phototoxic Reactions from Erythropoietic Protoporphyria

FDA Approves INREBIC (fedratinib) for Myelofibrosis

FDA Approves XENLETA (Lefamulin) Injection and Tablets for the Treatment of Adults with Community-Acquired Bacterial Pneumonia (CABP)

FDA Approved ROZLYTREK for ROS1-Positive Non-Small Cell Lung Cancer in Adults and Pediatric Patients 12 Years and Older

FDA Approves WAKIX for Excessive Daytime Sleepiness (EDS) in Adults with Narcolepsy

FDA Announces Availability of the Draft Guidance “Population Pharmacokinetics”

FDA Approves TURALIO (Pexidartinib) for Treatment of Adult Patients with Symptomatic Tenosynovial Giant Cell Tumor Associated with Severe Morbidity

FDA Announces Availability of the Draft Guidance, “M10 Bioanalytical Method Validation”

FDA Approves CORLANOR (Ivabradine) Oral Solution to Reduce the Risk of Hospitalization for Worsening Heart Failure in Adult Patients with Chronic Heart Failure 

FDA Announces Availability of a Final Guidance, “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations”

FDA Approves SKYRIZI for the Treatment of Moderate-to-Severe Plaque Psoriasis in Adults who are Candidates for Systemic Therapy or Phototherapy

FDA Approves MAYZENT for the Treatment of Relapsing Forms of Multiple Sclerosis

FDA Approves SPRAVATO with an Oral Antidepressant for the Treatment of TRD in Adults

FDA Approves ZULRESSO for Postpartum Depression in Adults

Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations

Bioavailability Studies Submitted in NDAs or INDs — General Considerations

FDA Approves EGATEN (Triclabendazole) for Fascioliasis in Patients 6 Years of Age or Older

FDA Approves ULTOMIRIS (Ravulizumab-cwvz) for Adult Patients with Paroxysmal Nocturnal Hemoglobinuria

2018 FDA Bursts

2017 FDA Bursts

2016 FDA Bursts