Brolucizumab-dbll (Beovu — Novartis), a vascular endothelial growth factor (VEGF) inhibitor, has been approved by the FDA as an intravitreal injection for treatment of neovascular (wet) age-related macular degeneration (AMD). It is the fourth VEGF inhibitor to be approved in the US for this indication; bevacizumab (Avastin, and others), a VEGF inhibitor FDA-approved for treatment of breast cancer and other malignancies, has been used off-label for this indication for years.

Romiplostim (Nplate - Amgen), a recombinant fusion protein injected subcutaneously, and eltrombopag (Promacta - GlaxoSmithKline), a non-peptide taken orally, have been approved by the FDA for treatment of chronic immune thrombocytopenic purpura (ITP) refractory to corticosteroids, immunoglobulins and/or splenectomy.

The FDA has approved IV amisulpride (Barhemsys – Acacia), a selective dopamine-2 and -3 (D₂/D₃) receptor antagonist, for prevention and treatment of postoperative nausea and vomiting (PONV) in adults. It is the first antiemetic to be approved for rescue treatment of PONV in patients who have symptoms despite receiving antiemetic prophylaxis. Oral formulations of amisulpride are available in Europe for treatment of schizophrenia and acute psychotic episodes.

Brinzolamide (Azopt - Alcon), a thieno-thiazine-6-sulfonamide carbonic anhydrase inhibitor, has been approved by the FDA in a 1% ophthalmic suspension for treatment of elevated intraocular pressure due to ocular hypertension or open-angle glaucoma. Brinzolamide is the second FDA-approved topical carbonic anhydrase inhibitor. Dorzolamide (Trusopt) was approved earlier (Medical Letter, 37:76, 1995).

On January 10, 2013, the FDA issued a news release to announce that it was requiring the manufacturers of the zolpidem-containing products Ambien, Ambien CR, Edluar and Zolpimist, which are all approved for treatment of insomnia, to lower the doses for women and to recommend in their labeling consideration of a lower dose for men. No change will be required in the dose of Intermezzo, a low-dose sublingual formulation of zolpidem for middle-of-the-night awakening, which is already recommended in a lower dose for women.

The FDA has approved Jentadueto XR (Boehringer Ingelheim/Lilly), a once-daily extended-release formulation of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin and the biguanide metformin, for oral treatment of type 2 diabetes. Linagliptin and metformin have been available for years in a twice-daily immediate-release combination (Jentadueto). Once-daily extended-release formulations combining metformin with the DPP-4 inhibitors saxagliptin (Kombiglyze XR) and sitagliptin (Janumet XR) are also available.

The FDA has approved venetoclax (Venclexta – Abbvie/Genentech), an oral selective BCL-2 inhibitor, for treatment of chronic lymphocytic leukemia (CLL) in patients with a 17p deletion who have received at least one prior therapy. The 17p deletion is associated with a poor prognosis in patients with CLL; it is prevalent in about 20% of patients with relapsed CLL. Venetoclax is the fi rst BCL-2 inhibitor to become available in the US.

The FDA has approved daxibotulinumtoxinA-lanm (Daxxify – Revance), an acetylcholine release inhibitor and neuromuscular blocking agent, for temporary improvement in the appearance of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity. Daxxify is the fifth botulinumtoxin type A product to be approved in the US for this indication (see Table 1). It is also approved for treatment of cervical dystonia in adults

The FDA has approved Admelog (Sanofi-Aventis), an insulin lispro product similar to Humalog (Lilly), which went off patent in 2013.Approval of Admelog was based on efficacy data with Humalog and on two 6-month, open-label, randomized, noninferiority trials. In SORELLA 11 in 507 patients with type 1 diabetes and SORELLA 22 in 505 patients with type 2 diabetes, Admelog was noninferior to Humalog in lowering A1C, fasting plasma glucose levels, and self-monitored plasma glucose levels. The incidence of adverse effects, including hypoglycemia, was similar.Even though Admelog is very similar to...

The FDA has approved the over-the-counter (OTC) sale of Rextovy (Amphastar), a nasal spray formulation of the opioid antagonist naloxone, for emergency treatment of opioid overdose. Other naloxone nasal sprays (Narcan, and generics; RiVive) are also available OTC (see Table 1).