Nadofaragene firadenovec-vncg (Adstiladrin – Ferring), an adenoviral vector-based gene therapy, has been approved by the FDA for treatment of adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. It is the first adenoviral vector-based gene therapy to be approved in the US for this indication. The immune checkpoint inhibitor pembrolizumab (Keytruda) was approved for the same indication in 2021.

Lasmiditan (Reyvow – Lilly), an oral serotonin (5-HT_1F) receptor agonist, and ubrogepant (Ubrelvy – Allergan), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, have been approved by the FDA for acute treatment of migraine with or without aura in adults.

Cefdinir (Omnicef - Parke-Davis), a third-generation oral cephalosporin, has been approved by the FDA for treatment of acute sinusitis, otitis media, acute exacerbations of chronic bronchitis, pharyngitis, community-acquired pneumonia and skin infections. Other drugs available for these indications are reviewed in The Medical Letter Handbook of Antimicrobial Therapy, 1998.

Gatifloxacin and moxifloxacin are now available for once-daily treatment of patients with community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, or acute sinusitis.

Fluticasone propionate, an inhaled corticosteroid, and salmeterol xinafoate, a long-acting beta2-adrenergic agonist, are now available together in a dry-powder inhaler for maintenance treatment of patients with asthma. The new combination is not recommended for treatment of acute bronchospasm or for treatment of children less than 12 years old.

Pramlintide acetate (Symlin - Amylin Pharmaceuticals), a synthetic analog of human amylin, has been approved by the FDA as adjunctive treatment for patients with type 1 or type 2 diabetes who inject insulin at mealtimes and have failed to achieve glucose control. Pramlintide is injected subcutaneously before meals.

Bendamustine HCl (Treanda - Cephalon), an unusual DNA-alkylating agent that has been used in Europe for many years to treat lymphoma, has now been approved by the FDA for treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).

Silodosin (Rapaflo - Watson Pharmaceuticals), an alpha1a-adrenoreceptor selective antagonist, has been approved by the FDA for treatment of benign prostatic hyperplasia (BPH). Some medications for BPH are listed in the table on page 4. Alpha1 blockers are commonly used with 5a-reductase inhibitors such as finasteride, which can shrink the size of the prostate, but may take months to do so.

The FDA has approved Basaglar (Lilly/Boehringer Ingelheim), a "follow-on" 100 units/mL insulin glargine product similar to Lantus (Sanofi), which recently went off patent. A 300 units/mL formulation of insulin glargine (Toujeo) was approved in 2015.

The FDA has approved an extended-release oral suspension formulation of amphetamine (Adzenys ER – Neos) for treatment of attention deficit hyperactivity disorder (ADHD) in patients ≥6 years old. The same extended-release amphetamine product is available as an orally disintegrating tablet and is marketed as Adzenys XR-ODT. Another extended-release oral suspension formulation of amphetamine, Dyanavel XR, was approved earlier.