FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD


August 01, 2018

In This Article

New Indications

Axillary Hyperhidrosis: Qbrexza (glycopyrronium tosylate topical)

Premoistened topical application cloth for treatment of primary axillary hyperhidrosis.

Bipolar I Disorder: Latuda (lurasidone)

Indicated as monotherapy for major depressive episode associated with bipolar I disorder (bipolar depression) in adolescents aged 10-17 years.

Irritable Bowel Syndrome: Trulance (plecanatide)

Indication for irritable bowel syndrome with constipation (IBS-C) in adults.

Kidney Function Decline: Jynarque (tolvaptan)

Indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)

Osteoporosis: Prolia (denosumab)

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.

Otitis Externa: Otiprio (ciprofloxacin otic)

New one-time single otic suspension administration for treatment of otitis externa in adults and children.

Overactive Bladder: Myrbetriq (mirabegron) and VESIcare (solifenacin)

Indicated in combination for treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency

Pemphigus Vulgaris: Rituxan (rituximab)

First drug approved in more 60 years for adults with moderate-to-severe pemphigus vulgaris (PV).


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