The FDA has approved an orally disintegrating tablet (ODT) formulation of rimegepant (Nurtec ODT – Biohaven), a small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant"), for acute treatment of migraine with or without aura in adults. Rimegepant is the second oral gepant to become available in the US; ubrogepant (Ubrelvy), which is approved for the same indication, was the first. Four parenteral CGRP antagonists, erenumab (Aimovig), fremanezumab (Ajovy), galcanezumab (Emgality), and eptinezumab (Vyepti), are approved for prevention of...

The FDA has approved a sublingual fi lm formulation of the nonergot dopamine agonist apomorphine (Kynmobi – Sunovion) for acute, intermittent treatment of "off" episodes in patients with Parkinson's disease (PD). A subcutaneous formulation of apomorphine (Apokyn) has been available for years for the same indication in patients with advanced PD.

The FDA has approved a long-acting fixed-dose combination of the stimulant dexmethylphenidate and the prodrug serdexmethylphenidate (Azstarys – Corium) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Azstarys is the first product containing serdexmethylphenidate to become available in the US.

The FDA has approved a 0.3% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of plaque psoriasis in patients ≥12 years old. Roflumilast is the first topical PDE4 inhibitor to be approved by the FDA for this indication; crisaborole (Eucrisa), another topical PDE4 inhibitor, is approved for treatment of atopic dermatitis. Oral roflumilast (Daliresp) is approved for treatment of chronic obstructive pulmonary disease.

Elafibranor (Iqirvo – Ipsen), a peroxisome proliferator-activated receptor (PPAR) agonist, has been granted accelerated approval by the FDA for treatment of primary biliary cholangitis (PBC) in adults. It is indicated for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso, and others) in patients with an inadequate response to UDCA alone and as monotherapy in those unable to tolerate UDCA.

The FDA has approved daridorexant (Quviviq – Idorsia), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. Daridorexant is the third orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) and lemborexant (Dayvigo) were approved earlier.

Loracarbef (Lorabid - Lilly), a new beta-lactam antibiotic with antimicrobial activity similar to the second-generation cephalosporins, has been approved by the US Food and Drug Administration for treatment of respiratory, skin, and urinary tract infection caused by susceptible organisms in both adults and children. It will probably compete with drugs such as trimethoprim-sulfamethoxazole (Bactrim, Septra, and others), amoxicillin-clavulanic acid (Augmentin), cefaclor (Ceclor), cefuroxime axetil (Ceftin), and cefprozil (Cefzil - Medical Letter, 34:63,...

Naltrexone (ReVia -DuPont Pharma), a long-acting oral opioid antagonist previously marketed for treatment of opioid dependence under the trade name Trexan, was recently approved by the US Food and Drug Administration (FDA) for treatment of alcohol dependence. The new trade name will now also be used for the old indication.

Bexarotene, a retinoid analog, has been approved by the US Food and Drug Administration for oral treatment of dermatologic manifestations of refractory cutaneous T-cell lymphoma.

Nelarabine (Arranon - GlaxoSmithKline), a prodrug of the deoxyguanosine analog 9-β-D-arabinofuranosylguanine (ara-G), has been approved by the FDA for treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) that has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.