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 July 2, 2021)

The FDA has approved the following drugs:
  • Restylane Contour to augment cheeks and improve midface contour imperfections in adults older than 21 years.
  • Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn) intramuscular injection as a component of a multi-agent chemotherapeutic regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adults and pediatric patients 1 month or older who have developed hypersensitivity to Escherichia coli–derived asparaginase.
The FDA has approved the following new indications:
  • Noxafil (posaconazole) intravenous injection and delayed-release oral tablets to treat invasive aspergillosis in adults and pediatric patients 13 years and older.
  • Solosec (secnidazole) oral granules to treat trichomoniasis caused by Trichomonas vaginalis in adults. Because trichomoniasis is a sexually transmitted disease with potentially serious consequences, partners of infected patients should be treated simultaneously to prevent reinfection.
  • Toviaz (fesoterodine fumarate) extended-release oral tablets to treat neurogenic detrusor overactivity in pediatric patients 6 years and older with a body weight greater than 25 kg. Toviaz is also approved to treat overactive bladder in adults with symptoms of urge urinary incontinence, urgency, and frequency.
The FDA has approved the following expanded indications:
  • Pradaxa (dabigatran etexilate) oral pellets to treat venous thromboembolic events (VTE) in pediatric patients 3 months to younger than 12 years who have been treated with a parenteral anticoagulant for at least 5 days, and to reduce the risk of recurrence of VTE in pediatric patients 3 months to 12 years who have been previously treated. The FDA has also approved an expanded indication for Pradaxa oral capsules to treat blood clots in patients 8 years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least 5 days, and to prevent recurrent clots in patients 8 years and older who completed treatment for their first venous thromboembolism. Pradaxa was previously indicated in adults only. Labeling includes a Boxed Warning regarding the risk of spinal/epidural hematoma and the increased risk of thrombotic events with premature discontinuation of PradaxaPradaxa is the first FDA-approved blood thinning medication that children can take orally.
The FDA is working to improve a critical shortage:
  • The FDA is working to mitigate a critical shortage of US-licensed asparaginase erwinia chrysanthemi injection, powder, lyophilized, for solution in the US market, by making the non–FDA licensed Erwinase (crisantaspase) 10,000 IU/vial powder for injection/infusion available in the United States. However, this is not a formal FDA approval of ErwinaseErwinase is indicated in patients 4 months and older as a component of a chemotherapeutic regimen to treat patients with acute lymphoblastic leukemia who have developed hypersensitivity to Escherichia coli–derived asparaginase. 
  

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