Drug News

Stay up-to-date on the latest drug news. Learn about new drug approvals, labeling changes, expanded indications, recalls, and approvals of generic formulations. These drug news updates are compiled from the latest information from Facts & Comparisons® and the U.S. Food and Drug Administration.

DRUG NEWS
(Updated February 5, 2019)

The FDA has approved the following drug:
  • Jeuveau (prabotulinumtoxinA-xvfs) intramuscular injection to temporarily improve the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. Labeling includes a Boxed Warning regarding the risk of distant spread of toxin effect.
The FDA has approved the following new indication:
  • Osphena (ospemifene) oral tablets to treat moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause. Osphena is already approved to treat moderate to severe dyspareunia secondary to menopause. Labeling includes a Boxed Warning regarding the risk of endometrial cancer and cardiovascular disorders.
The FDA has approved the following expanded indications:
  • Alimta (pemetrexed) intravenous injection, in combination with pembrolizumab and platinum chemotherapy, to initially treat patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. Alimta is also approved in combination with carboplatin and pembrolizumab for initial treatment of metastatic nonsquamous NSCLC; in combination with cisplatin to initially treat patients with locally advanced or metastatic, nonsquamous NSCLC; as a single agent for the maintenance treatment of patients with locally advanced or metastatic, nonsquamous NSCLC whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy; as a single agent to treat patients with recurrent, metastatic nonsquamous NSCLC after prior chemotherapy; and in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are not candidates for curative surgery.
  • Imbruvica (ibrutinib) oral capsules and tablets in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Imbruvica is also approved for treatment of CLL/SLL either as monotherapy or in combination with bendamustine and rituximab, as well as for CLL/SLL with 17p deletion, refractory chronic graft-versus-host disease, previously treated mantle cell lymphoma, relapsed/refractory marginal zone lymphoma, and Waldenström macroglobulinemia.

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