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FDA News Briefs for Tuesday, November 20, 2018

November 20, 2018

These Food and Drug Administration (FDA) developments came in last Friday:


FDA Approves New Indication for Adcetris

The FDA approved Adcetris (brentuximab vedotin; Seattle Genetics Inc.) for a sixth indication under its new Real-Time Oncology Review (RTOR) program. Adcetris is now approved for first-line treatment of systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone. More Information.


New Drug Approved for Travelers’ Diarrhea

The FDA approved Aemcolo (rifamycin; Cosmo Technologies Ltd.) 194 mg delayed-release tablets to treat travelers’ diarrhea complicated by fever or bloody stool or due to pathogens other than noninvasive strains of Escherichia coli. More Information.


Promacta Now Indicated for First-Line Treatment of Severe Aplastic Anemia

The FDA expanded indications for Promacta (eltrombopag; Novartis) to include use in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years of age and older with severe aplastic anemia. More Information.