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 June 12, 2018)

The FDA has approved the following drugs:
 
  • Fulphila (pegfilgrastim-jmdb) subcutaneous injection, a biosimilar to Neulasta (pegfilgrastim), to reduce infection (febrile neutropenia) in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
The FDA has approved the following expanded indications:
 
  • Alimta (pemetrexed), intravenous injection, to include the initial treatment of patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status (in combination with carboplatin and pembrolizumab). Alimta is also approved for initial treatment of unresectable malignant pleural mesothelioma (in combination with cisplatin) or in patients who are not candidates for curative surgery; initial treatment of locally advanced or metastatic nonsquamous NSCLC (in combination with cisplatin); maintenance treatment of locally advanced or metastatic nonsquamous NSCLC if no progression after 4 cycles of initial platinum-based first-line therapy; and as a single-agent treatment (after prior chemotherapy) of recurrent/metastatic nonsquamous NSCLC.
  • Mircera (methoxy polyethylene glycol-epoetin beta) intravenous injection to include the treatment of anemia associated with chronic kidney disease (CKD) in pediatric patients ages 5 to 17 years on hemodialysis who are transitioning from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA. Mircera is also indicated to treat anemia associated CKD in adult patients on or not on dialysis. Labeling includes a Boxed Warning regarding the increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.
  • Restylane Lyft (hyaluronic acid) cosmetic injection to include injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21 years. Restylane Lyft is also approved for cheek augmentation and correction of facial wrinkles and folds.
  • Venclexta (venetoclax) oral tablets to include treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, with or without 17p deletion, who have received at least 1 prior therapy. Venclexta was previously approved only to treat CLL in patients with 17p deletion who have received at least 1 prior therapy.  
 

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