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 9, 2020)

The FDA has approved the following drugs:
  • Cystadrops (cysteamine) ophthalmic topical solution to treat corneal cystine crystal deposits in adults and children with cystinosis.
  • Qdolo (tramadol hydrochloride) oral solution in adults to manage severe pain requiring an opioid analgesic where alternative treatments are inadequate. Labeling includes a Boxed Warning regarding the risk of medication errors; addiction, abuse, and misuse; the opioid analgesic REMS; life-threatening respiratory depression; accidental ingestion; ultra-rapid metabolism of tramadol and other risk factors for life-threatening respiratory depression in children; neonatal opioid withdrawal syndrome; interactions with drugs affecting cytochrome P450 isoenzymes; and risks from concomitant use with benzodiazepines and other CNS depressants.
  • Sogroya (somapacitan-beco) subcutaneous injection as a replacement for endogenous growth hormone in adults with growth hormone deficiency.
  • Winlevi (clascoterone) cream to treat acne vulgaris in patients 12 years and older.
  • Xaracoll (bupivacaine hydrochloride) implant within surgical sites in adult patients to reduce postsurgical pain for up to 24 hours following open inguinal hernia repair. 
The FDA has approved the following expanded indications:
  • Ultravate (halobetasol propionate) topical lotion for to treat plaque psoriasis in patients 12 years and older. Ultravate was previously approved in patients 18 years and older.

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