Idarubicin hydrochloride (Idamycin - Adria), an anthracycline structurally related to daunorubicin (Cerubidine, and others) and doxorubicin (Adriamycin, and others), was recently approved in the USA for treatment of acute myelogenous leukemia (AML) in adults.

Ropivacaine (Naropin - Astra), like bupivacaine (Marcaine, and others), is a member of the mepivacaine (Carbocaine, and others) family of local anesthetics. Bupivacaine has been an effective long-acting local anesthetic, but with overdosage or inadvertent intravascular injection, it can cause severe cardiotoxicity, which may not be reversible. Ropivacaine is claimed to be less cardiotoxic. It has been approved by the FDA for local or regional block for surgery, obstetrical procedures and postoperative pain management.

The FDA has approved a delayed-release oral formulation of prednisone (Rayos – Horizon Pharma). Rayos is not labeled for any specific indication, but the only published studies of the new product have been in patients with rheumatoid arthritis (RA).

Bellafill (Suneva), a dermal filler approved earlier for correction of nasolabial folds, has now also been approved by the FDA for correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in adults ≥21 years old. It is the only dermal filler approved in the US for correction of facial acne scars.

The FDA has approved Fluad (Seqirus), an adjuvanted trivalent seasonal influenza vaccine, for immunization of adults ≥65 years old. It will become available later this year for use during the 2016-2017 influenza season. Fluad is the second influenza vaccine to be approved in the US specifically for older adults; Fluzone High-Dose was the first. Fluad has been available in other countries for many years.

The results of a clinical trial (PRECISION) comparing the cardiovascular safety of the COX-2 selective NSAID celecoxib (Celebrex, and generics) with that of ibuprofen and naproxen, which are nonselective, have been described in the lay press in terms that may overestimate the safety of celecoxib.

The FDA has approved an over-the-counter (OTC) 0.025% ophthalmic formulation of the selective alpha₂-adrenergic agonist brimonidine tartrate (Lumify – Bausch & Lomb) for treatment of ocular redness in adults and children ≥5 years old. Lumify is the first brimonidine product to be approved for OTC use.

On June 25, 2021, the FDA added a warning to the Fact Sheets for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) about an increased risk of myocarditis and pericarditis following administration of the vaccines.

View the Table: GLP-1 and GIP/GLP-1 Receptor Agonists for Chronic Weight Management

The FDA has approved two subcutaneously injected calcitonin gene-related peptide (CGRP) antagonists, fremanezumab-vfrm (Ajovy – Teva) and galcanezumab-gnlm (Emgality – Lilly), for migraine prevention in adults. Fremanezumab and galcanezumab are the second and third subcutaneously injected monoclonal antibodies that target the CGRP pathway to be approved by the FDA for this indication; erenumab-aooe (Aimovig), which targets the CGRP receptor, was the first.