2018 FDA Bursts

FDA Approves ELZONRIS Injection for Blastic Plasmacytoid Dendritic Cell Neoplasm

FDA Approves DAURISMO (Glasdegib) in Combination with Low-Dose Cytarabine for the Treatment of Newly-Diagnosed Acute Myeloid Leukemia (AML) in Adult Patients

FDA Approves VITRAKVI (Larotrectinib) for Certain Solid Tumors with NTRK Gene Fusions

FDA Approves AEMCOLO (Rifamycin) for the Treatment of Travelers’ Diarrhea Caused by Noninvasive Strains of Escherichia Coli in Adults

Revises Certain Antiretroviral Drug Labeling to Not Recommend Cobicistat During Pregnancy

FDA Approves TALZENNA (Talazoparib) for the Treatment of Deleterious or Suspected Deleterious Germline BRCA-mutated (gBRCAm) HER2‑Negative Locally Advanced or Metastatic Breast Cancer in Adults

FDA Approves LORBRENA (Lorlatinib) for Anaplastic Lymphoma Kinase-Positive Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed on Certain Other Kinase Inhibitors

FDA Approves XOFLUZA for Acute Uncomplicated Influenza in Patients 12 Yrs of Age and Older Who Have Been Symptomatic for No More than 48 Hrs

FDA Announces Availability of the Final Guidance “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease”

FDA Approves NUZYRA (Omadacycline) for Community-Acquired Bacterial Pneumonia and for Acute Bacterial Skin and Skin Structure Infections in Adults

FDA Approves SEYSARA (Sarecycline) for Inflammatory Lesions of Non-Nodular Moderate to Severe Acne Vulgaris in Patients 9 Years of Age and Older

FDA Approves VIZIMPRO: Metastatic Non‑small Cell Lung Cancer with Epidermal Growth Factor Receptor Exon 19 Deletion Exon 21 L858R Mutations

FDA Approves POTELIGEO (Mogamulizumab-kpkc) for Treatment of Adult Patients with Relapsed or Refractory Mycosis Fungoides or Sézary Syndrome After At Least One Prior Systemic Therapy

FDA Approves PIFELTRO in Combination w/Other Antiretroviral Agents for HIV-1 Infection in Adult Patients w/no Prior Antiretroviral Treatment

FDA Approves DELSTRIGO for the Treatment of HIV-1 Infection in Adult Patients with no Antiretroviral Treatment History

FDA Announces Availability of the Final Guidance, “Physiologically Based Pharmacokinetic Analyses
Format and Content”

FDA Approves XERAVA (Eravacycline) for Complicated Intra-Abdominal Infections in Patients 18 Years of Age and Older

FDA Approves DIACOMIT (Stiripentol) for Seizures Associated with Dravet syndrome in Patients 2 Years of Age and Older Taking Clobazam

FDA Approves MULPLETA (Lusutrombopag) for the Treatment of Thrombocytopenia in Adult Patients with Chronic Liver Disease

FDA Approves KRINTAFEL (tafenoquine) for Radical Cure of Plasmodium Vivax malaria in Patients Aged 16 Years and OIder who are Receiving Appropriate Antimalarial Therapy for Acute P. Vivax Infection

FDA Approves TIBSOVO for Relapsed or Refractory Acute Myeloid Leukemia with Susceptible IDH1 Mutation

FDA Approves TPOXX (Tecovirimat) for the Treatment of Human Smallpox Disease

FDA Approves BRAFTOVI & MEKTOVI for Unresectable or Metastatic Melanoma with a BRAF V600E or V600K Mutation

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