The FDA has approved Technivie (Abbvie), a fixed-dose combination of the direct-acting antiviral agents ombitasvir and paritaprevir and the pharmacokinetic enhancer ritonavir, for oral treatment of chronic hepatitis C virus (HCV) genotype 4 infection in patients without cirrhosis. It is indicated for use in combination with ribavirin. Ombitasvir/paritaprevir/ritonavir copackaged with dasabuvir, an HCV RNA polymerase inhibitor that has little activity against HCV genotype 4, is approved as Viekira Pak for treatment of HCV genotype 1 infection.1HCV genotype 4 is uncommon in the US and Canada. It...

The FDA has approved the use of subcutaneous injections of deoxycholic acid (Kybella – Kythera/Allergan) to improve the appearance of moderate to severe convexity or fullness associated with submental fat (double chin) in adults. It is the first drug approved for this indication.

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has been approved by the FDA for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangements. It is the first targeted therapy to be approved in the US for this indication. The drug received accelerated approval from the FDA in 2020 for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or other rearrangements.

Cosibelimab (Unloxcyt – Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, has been approved by the FDA for treatment of locally advanced or metastatic cutaneous squamous cell carcinoma in adults who are not candidates for curative surgery or radiation. It is the first PD-L1 inhibitor to be approved in the US for this indication. The PD-1 inhibitors pembrolizumab (Keytruda) and cemiplimab (Libtayo) are also approved for treatment of cutaneous squamous cell carcinoma.

Zusduri (UroGen), a mitomycin-based solution for intravesical instillation, has been approved by the FDA for treatment of recurrent low-grade intermediate-risk nonmuscle invasive bladder cancer (NMIBC) in adults. It is the first drug to be approved in the US for this indication. Mitomycin has been available for years for treatment of various malignancies.

Flurbiprofen (Ansaid - Upjohn), a nonsteroidal anti-inflammatory drug (NSAID) available in some countries since 1977, was recently approved by the US Food and Drug Administration for treatment of rheumatoid arthritis and osteoarthritis. Flurbiprofen is a fluorinated phenylalkanoic acid derivative structurally related to ibuprofen (Motrin;and others).

Dezocine (Dalgan - Astra), a new synthetic opioid agonist/antagonist structurally related to pentazocine (Talwin), was recently approved for parenteral use as an analgesic by the US Food and Drug Administration.

The enzyme alpha-galactosidase (Beano - AkPharma), derived from a mold and classified as a food, is sold without presecription in pharmacies and food stores. The manufacturer recommends taking the anzyme to decrease intestinal gas producted by eating the high-fiber diets now widely recommended in the USA.

Epoprostenol sodium (Flolan - Glaxo Wellcome), also known as prostacyclin, has been approved by the US Food and Drug Administration for continuous intravenous treatment of primary pulmonary hypertension.

Temozolomide has received accelerated approval from the FDA for oral treatment of adults with anaplastic astrocytoma that has relapsed after treatment with a nitrosourea (lomustine or carmustine) and procarbazine.