Articles related to PRODUCT LABELING

The FDA expanded the indication for olopatadine hydrochloride and mometasone furoate nasal spray to include children aged 6 to younger than 12 years with seasonal allergic rhinitis. Approval was supported by a phase 3 trial demonstrating improved nasal symptoms versus placebo.

The FDA issued a Class II recall for an amphetamine-based ADHD medication after a labeling mix-up resulted in immediate-release capsules being packaged as extended release. The recall affects a single lot totaling 1,392 bottles.

The FDA approved a supplemental NDA adding randomized withdrawal trial data to the lumateperone label, supporting its role in long-term maintenance and relapse prevention in adults with schizophrenia.

Although most of these patients had no response to multiple seizure medications, the 9 who were treated with vitamin B6 supplementation had resolution of their seizures.

“We are delivering on our promise to make sure women have accurate, scientifically grounded information about the potentially life-changing benefits of HRT.” — FDA Commissioner Marty Makary, MD, MPH

As pharmacists, it’s crucial to note that, although these changes in FDA guidelines may not directly impact your practice, they signify a shift in how biosimilars will be identified moving forward. This could potentially influence how you advise patients about these products.