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 PALYNZIQ to Reduce Blood Phenylalanine Concentrations in Adult Patients with Phenylketonuria who have Uncontrolled Blood Phenylalanine Concentrations

FDA Approves DOPTELET to Treat Thrombocytopenia in Adult Patients with Chronic Liver Disease Scheduled to Undergo a Procedure

FDA Issue Draft Guidance, “Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations”


FDA Announces Availability of a Public Docket, “Framework for Assessing pH-Dependent Drug-Drug Interactions”


FDA Announces Availability of a Final Guidance, “Bioanalytical Method Validation”

FDA Approves LUCEMYRA for Mitigation of Opioid Withdrawal Symptoms to Facilitate Abrupt Opioid Discontinuation in Adults

FDA Announces Availability of a Public Docket, “Framework for Assessment of Drug-Drug Interactions for Therapeutic Proteins”


FDA Approves CRYSVITA to Treat X-Linked Hypophosphatemia in Adults and Pediatric Patients 

FDA Approves ILUMYA for Adult Plaque Psoriasis


FDA Approves TROGARZO (ibalizumab-uiyk)

FDA Announces Availability of the Guidance, “E18 Genomic Sampling and Management of Genomic Data”

FDA Approves BIKTARVY (bictegravir, embitcitabine, tenofovir alafenamide) for HIV-1 Infection in Adults Who Have No Antiretroviral Treatment History or to Replace Current Antiretroviral Regimen in Those Who Are Virologically Suppressed

FDA Announces Draft Guidance Labeling for Combined Hormonal Contraceptives


2017 FDA Bursts

2016 FDA Bursts