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.

(Updated September 19, 2017)

The FDA has approved the following drugs:‚Äč
  • Aliqopa (copanlisib) intravenous injection to treat adults with relapsed follicular lymphoma who have received at least 2 prior systemic therapies. 
  • Solosec (secnidazole) oral granules to treat bacterial vaginosis in adult women.
  • Mvasi (bevacizumab-awwb) solution for intravenous infusion as a biosimilar product to Avastin (bevacizumab) to treat:
    • Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy, for first- or second-line treatment.
    • Metastatic colorectal cancer, with fluoropyrimidine-irinotecan–or fluoropyrimidine-oxaliplatin–based chemotherapy, for second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen.
    • Non-squamous, non-small cell lung cancer, with carboplatin and paclitaxel, for first-line treatment of unresectable, locally advanced, recurrent, or metastatic disease.
    • Glioblastoma, as a single agent for adults with progressive disease following prior therapy. No available data demonstrate improvement in disease-related symptoms or survival with bevacizumab products.
    • Metastatic renal cell carcinoma, with interferon alfa.
    • Cervical cancer, with paclitaxel and cisplatin or paclitaxel and topotecan, in persistent, recurrent, or metastatic disease.
               Mvasi labeling includes a Boxed Warning regarding the risk of gastrointestinal perforations, surgery and                            wound healing complications, and hemorrhage. Mvasi is not indicated for adjuvant treatment of colon cancer.
 
The FDA has approved the following expanded indication:
  • Aptiom (eslicarbazepine acetate) oral tablets to treat partial-onset seizures in patients 4 years and older. Aptiom was previously approved for this indication in adult patients only. 
  • Briviact (brivaracetam) oral tablets, oral solution, and intravenous injection to include use as monotherapy for the treatment of partial-onset seizures in patients 16 years and older with epilepsy. Briviact was initially approved as adjunctive therapy only. 
  • Somatuline Depot (lanreotide) subcutaneous injection to include the treatment of adults with carcinoid syndrome, reducing the frequency of short-acting somatostatin analogue rescue therapy. Somatuline Depot is also approved for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors.

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