Implanted devices that monitor cardiac rhythm and can recognize and treat ventricular tachycardia or ventricular fibrillation are now widely used in the USA and other countries. Implantable cardioverter/defibrillators (ICDs) marketed here include the Ventak P and PRX (Cardiac Pacemakers, Inc., St. Paul, MN), the PCD (Medtronic, Minneapolis, MN), and the Cadence (Ventritex, Sunnyvale, CA) (JG Porterfield et al, Am J Cardiol, 72:301, 1993).

Tacrolimus ointment (Protopic) has been approved by the FDA in 0.03% and 0.1% formulations for treatment of atopic dermatitis. Tacrolimus is used systemically (Prograf) to prevent rejection of organ transplants.

Botulinum toxin type A (Botox - Allergan) and type B (Myobloc - Elan) are now approved by the FDA for treatment of cervical dystonia. Botulinum toxin type A has been approved since 1989 for treatment of strabismus and blepharospasm. It is also used cosmetically to reduce wrinkles on the face and neck.

Full-page newspaper advertisements are urging patients with high cholesterol levels who are stopping Baycol (cerivastatin) to ask their doctors about Pravachol (pravastatin), Lipitor (atorvastatin), Zocor (simvastatin) or Lescol (fluvastatin). Some advertisements come with a coupon for free medication. Lovastatin, which is available generically, has not appeared in similar advertisements. Cerivastatin was withdrawn from the market on August 8 because of post-marketing reports of 31 cases of fatal rhabdomyolysis.

Recently pharmaceutical manufacturers have marketed a stereoisomer of a successful drug nearing patent expiration as a new drug. Examples, such as esomeprazole (Nexium) , levalbuterol (Xopenex), escitalopram (Lexapro) and dexmethylphenidate

An injectable gel of hyaluronic acid (Restylane) has been approved by the FDA for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Manufactured by Q-Med AB, a Swedish company, it has been used outside the US since 1996.

Palifermin (Kepivance - Amgen), a recombinant human keratinocyte growth factor (KGF), has been approved by the FDA to decrease the incidence and duration of severe oral mucositis (OM) in patients with hematologic malignancies receiving myelotoxic chemotherapy and hematopoietic stem cell (HSC) rescue.

In the past 2 years, the FDA has approved 3 new drugs for prevention or treatment of hereditary angioedema (HAE) in non-pregnant adolescents and adults: the C1 esterase inhibitor Cinryze for prophylaxis and the C1 esterase inhibitor Berinert and the kallikrein inhibitor ecallantide (Kalbitor) for treatment of acute attacks.

The FDA has approved efinaconazole 10% solution (Jublia – Valeant) for topical treatment of toenail onychomycosis due to Trichophyton rubrum and/or Trichophyton mentagrophytes. It is the first topical triazole antifungal drug to be approved for this indication. A topical oxaborole antifungal solution, tavaborole 5% (Kerydin – Anacor), also recently approved by the FDA for the same indication will be reviewed in a future issue.

The FDA has approved Incruse Ellipta (GSK), a single-agent inhaler containing the long-acting anticholinergic umeclidinium, for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Umeclidinium was initially approved in combination with the long-acting beta₂-adrenergic agonist vilanterol as Anoro Ellipta.