Premoistened topical application cloth for treatment of primary axillary hyperhidrosis.
Indicated as monotherapy for major depressive episode associated with bipolar I disorder (bipolar depression) in adolescents aged 10-17 years.
Indication for irritable bowel syndrome with constipation (IBS-C) in adults.
Indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)
Indicated for glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids equivalent to 7.5 mg/day or more of prednisone and are expected to remain on glucocorticoids for at least 6 months.
New one-time single otic suspension administration for treatment of otitis externa in adults and children.
Indicated in combination for treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
First drug approved in more 60 years for adults with moderate-to-severe pemphigus vulgaris (PV).
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.