The FDA has approved an extended-release orally disintegrating tablet formulation of methylphenidate (Cotempla XR-ODT – Neos Therapeutics) for once-daily treatment of attention-defi cit/hyperactivity disorder (ADHD) in children 6-17 years old. Cotempla XR-ODT is the first extended-release orally disintegrating tablet formulation of methylphenidate to become available in the US.

The FDA has approved Roxybond (Daiichi Sankyo), an short-acting (SA) oxycodone formulation with abuse-deterrent properties, for treatment of pain requiring management with an opioid. Roxybond is the first SA opioid to be approved as an abuse-deterrent product. Oxaydo, another IR oxycodone formulation, has properties that discourage its intranasal and intravenous use, but is not considered an abuse-deterrent product by the FDA. Use of opioids for treatment of pain was reviewed in a recent issue.

The FDA has approved revefenacin (Yupelri – Mylan/Theravance Biopharma), a long-acting antimuscarinic agent (LAMA) administered once daily by standard jet nebulizer, for maintenance treatment of chronic obstructive pulmonary disease (COPD). Revefenacin is the second nebulized LAMA to be approved for this indication; glycopyrrolate (Lonhala Magnair), which is administered twice daily with a portable handheld nebulizer, was the first.

The FDA has approved cyclosporine 0.09% ophthalmic solution (Cequa – Sun) to increase tear production in patients with keratoconjunctivitis sicca (dry eye disease). Restasis, a 0.05% cyclosporine emulsion, was approved in the US in 2003 for the same indication.

The FDA has approved darolutamide (Nubeqa – Bayer), an androgen receptor inhibitor, for oral treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). Darolutamide is the third androgen receptor inhibitor to be approved for this indication; apalutamide (Erleada) and enzalutamide (Xtandi), which are also approved for use in patients with metastatic castration-resistant prostate cancer (mCRPC), were approved earlier.

Over-the-counter products containing melatonin are widely used as sleep aids in children and adults.

The FDA has approved an intracameral implant containing the prostaglandin analog bimatoprost (Durysta – Allergan) for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Bimatoprost is also available in 0.01% (Lumigan) and 0.03% (generics) ophthalmic solutions for the same indication and in a 0.03% solution (Latisse, and generics) for eyelash enhancement. Durysta is the first ocular implant to become available in the US for treatment of glaucoma.

The FDA has approved insulin lispro-aabc (Lyumjev – Lilly), a faster-acting formulation of insulin lispro (Humalog), for treatment of type 1 and type 2 diabetes in adults. Fiasp, a faster-acting formulation of insulin aspart (Novolog), was approved in 2017.

The FDA has approved the antiviral drug remdesivir (Veklury – Gilead) for IV treatment of COVID-19 in hospitalized patients who are ≥12 years old and weigh ≥40 kg. Hospitalized children who are <12 years old or weigh <40 kg can receive remdesivir through an Emergency Use Authorization (EUA). Remdesivir is the first drug to be approved in the US for treatment of COVID-19.

The FDA has approved the oral tyrosine kinase inhibitor ripretinib (Qinlock – Deciphera) for treatment of adults with advanced gastrointestinal stromal tumors (GISTs) who have previously received treatment with ≥3 kinase inhibitors, including imatinib (Gleevec, and generics).