Monica Holmberg, PharmD, BCPS

The FDA has approved Rinvoq (upadacitinib) to treat moderate to severe rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to methotrexate (MTX).

The FDA has approved Xenleta (Lefamulin, from Nabriva Therapeutics) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms.

The FDA has approved Sunosi (solriamfetol) from Jazz Pharmaceuticals, Inc, to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

The FDA has approved Descovy (emtricitabine 200-mg and tenofovir alafenamide 25-mg tablets) for HIV-1 pre-exposure prophylaxis (PrEP).

PPD affects about 1 in 9 women who have given birth in the United States. The onset of PPD can occur during pregnancy or after delivery, and symptoms include anxiety, irritability, sadness, thoughts of harm to the baby or self-harm, trouble bonding with the baby, and withdrawal from family or friends.

The FDA has approved Zulresso (brexanolone), from Sage Therapeutics, injection to treat postpartum depression (PPD) in adults.1

Teva Pharmaceuticals Inc has released Ajovy (fremanezumab-vfrm) injection in the United States, following approval by the FDA for preventive treatment of migraines in adults.

The FDA has approved Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, from Aerie Pharmaceuticals, Inc, for the reduction of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.

Amgen is indicated to treat osteoporosis in postmenopausal women at high risk for fracture.

The FDA has approved Annovera (segesterone acetate and ethinyl estradiol vaginal system) from TherapeuticsMD and the Population Council for pregnancy prevention.

The FDA has approved orilissa (elagolix; AbbVie Inc) to manage moderate to severe pain asso- ciated with endometriosis.

The FDA has approved Ilumya (tildrakizum- ab-asmn) from Sun Pharmaceutical Industries Ltd to treat moderate to severe plaque psoriasis.

The FDA has approved olumiant to treat moderately to severely active rheumatoid arthritis.

Teva Pharmaceutical Industries Ltd has released Qvar Redihaler (beclomethasone dipropionate HFA).

The FDA has approved Lyrica CR (pregabalin, Pfizer) for the management of neuropathic pain associated with diabetic peripheral neuropathy or postherpetic neuralgia.

The FDA has approved Duzallo (lesinurad and allopurinol; Ironwood Pharmaceuticals, Inc) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone.

The FDA has approved Tremfya (guselkumab, Janssen Biotech, Inc) for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The fda has approved mydayis (mixed salts of a single-entity amphetamine product, by Shire) to treat attention deficit hyperactivity disorder (ADHD) in patients 13 years or older.

The FDA has approved ingrezza capsules for the treatment of adults with tardive dyskinesia.

The FDA has approved Qtern tablets by AstraZeneca to improve glycemic control in adults with type 2 diabetes.

Both trials found that patients using Intrarosa demonstrated a significant reduction in the severity of pain during intercourse compared with the placebo.

The FDA has approved an expanded indication for Spiriva Respimat for the long-term, once-daily maintenance treatment of asthma in patients 6 years and older.

The FDA has approved an expanded indication for Tresiba to improve glycemic control in patients with diabetes as young as 1 year.

The FDA has approved Yosprala (aspirin and omeprazole, Aralez Pharmaceuticals) delayed-release tablets for patients requiring aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.

The FDA has approved Stelara injection for the treatment of adults with moderately to severely active Crohn’s disease who have failed, or were intolerant to, treatment with immunomodulators or corticosteroids.

Synjardy has received FDA approval for an expanded indication to include treatment-naïve adults with type 2 diabetes