Trastuzumab (Herceptin - Genentech), a recombinant 'humanized' monoclonal antibody (rhuMAb) that binds to a protein encoded by the oncogene HER2, and capecitabine (ka pe site' a been; Xeloda - Roche), an oral pro-drug for 5-fluorouracil, have been approved by the FDA for treatment of metastatic breast cancer.

Botulinum toxin type A (Botox Cosmetic - Allergan) has received formal approval from the FDA for treatment of glabellar ("frown") lines in adults not more than 65 years old, and is being heavily advertised. Even before this approval, cosmetic use of botulinum toxin to reduce wrinkles on the face and neck had become a popular alternative to cosmetic surgery (Medical Letter 1999; 41:63). Botulinum toxin type A (Botox) and type B (Myobloc) are approved for treatment of cervical dystonia (Medical Letter 2001; 43:53), and type A has been approved since 1989 for treatment of strabismus and...

Pimecrolimus 1% cream (pim e kroe' limus; SDZ ASM 981; Elidel - Novartis) has been approved by the FDA for short-term and intermittent long-term treatment of mild to moderate atopic dermatitis in non-immunocompromised patients at least 2 years old.

The FDA has approved subcutaneous injection of methylnaltrexone (Relistor - Wyeth/Progenics), a selective mu-opioid receptor antagonist, for treatment of opioid-induced constipation in patients with advanced illness (such as incurable cancer or end-stage chronic obstructive pulmonary disease) who are receiving palliative care.

Ramucirumab (Cyramza – Lilly), a monoclonal antibody that inhibits vascular endothelial growth factor receptor 2 (VEGFR2), has been approved by the FDA for use as monotherapy or in combination with paclitaxel for treatment of advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after platinum- or fluoropyrimidine-based chemotherapy. Ramucirumab is also approved for use in combination with docetaxel (Taxotere, and others) for treatment of metastatic non-small cell lung cancer that has progressed on or after platinum-based...

The FDA has approved rolapitant (Varubi – Tesaro), an oral substance P/neurokinin 1 (NK₁) receptor antagonist, for use with other antiemetics to prevent delayed nausea and vomiting associated with cancer chemotherapy in adults. It is the third substance P/NK₁ receptor antagonist to be approved in the US; aprepitant (Emend) and netupitant (only available in combination with the 5-HT₃ receptor antagonist palonosetron as Akynzeo) were approved earlier for prevention of both acute and delayed chemotherapy-induced nausea and vomiting.

The FDA has approved the Obalon Balloon System (Obalon), a swallowable intragastric gas-filled balloon device, to facilitate weight loss in adults with a body mass index (BMI) of 30-40 kg/m² who have not been able to lose weight through diet and exercise. Two other gastric balloon devices, ReShape and Orbera, were approved earlier.

The FDA has approved Entadfi (Veru), a fixed-dose combination of the 5α-reductase inhibitor finasteride and the phosphodiesterase type 5 (PDE5) inhibitor tadalafil, for initial treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate; use of the drug is limited to 26 weeks. Entadfi is the first 5α-reductase inhibitor/PDE5 inhibitor combination to become available in the US. Finasteride (Proscar, and generics) and tadalafil (Cialis, and generics) are also available separately.

Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the second nonhormonal treatment to be approved in the US for this indication; a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle) was approved in 2013.

Givinostat (Duvyzat – Italfarmaco), an oral histone deacetylase inhibitor, has been approved by the FDA for treatment of patients ≥6 years old with Duchenne muscular dystrophy (DMD), regardless of the DMD-causing mutation. It is the first nonsteroidal drug to be approved for this indication. The oral corticosteroids deflazacort (Emflaza) and vamorolone (Agamree) are also approved for treatment of patients with all genetic variants of DMD.