Two new topical testosterone products, a 1% gel (Testim) and a buccal tablet (Striant), have been approved by the FDA for treatment of hypogonadism in men. This review briefly describes hypogonadism and its causes and lists other available formulations of testosterone. For the new products, information on pharmocokinetics, adverse effects, and dosage and administration is provided, as well as a summary of clinical trial results. A dosage and cost table for topical testosterone products is also included. The conclusion summarizes the safety and effectiveness of the new drugs and discusses the...

The FDA has approved the marketing of a 10% topical gel formulation of the muscarinic receptor antagonist oxybutynin chloride (Gelnique - Watson) for treatment of overactive bladder. Oxybutynin is also available for this indication as oral tablets, an oral syrup and a transdermal patch.

Clarithromycin (Biaxin - Abbott) and azithromycin (Zithromax - Pfizer), two macrolide antibiotics chemically related to erythromycin, have been approved by the US Food and Drug Administration for treatment of respiratory, skin, and skin structure infections. Azithromycin has also been approved for treatment of nongonococcal urethritis and cervicitis caused by Chlamydia trachomatis.

Several injectable products are available for soft tissue augmentation of wrinkles and folds. These fillers are often used in conjunction with botulinum toxin type A (Botox) injections.

The FDA has approved calcitriol ointment (Vectical - Galderma), a vitamin D analog, for topical treatment of mild-to-moderate plaque psoriasis in adults ≥18 years old. Ointments are generally considered more potent than creams or solutions.

A patient-controlled fentanyl iontophoretic transdermal system (Ionsys – The Medicines Company) is now available for short-term management of acute postoperative pain in adults requiring opioid analgesia in the hospital. Before using Ionsys, patients must be titrated to a comfortable level of analgesia with another opioid formulation.

The FDA has approved Enstilar (Leo), an aerosol foam formulation of the synthetic vitamin D₃ analog calcipotriene and the high-potency corticosteroid betamethasone dipropionate, for topical treatment of plaque psoriasis in adults. Topical ointment and suspension formulations of the same combination have been available for many years.

The FDA has approved a 10% nanoemulsion gel formulation of the porphyrin-based photosensitizer aminolevulinic acid hydrochloride (ALA; Ameluz – Biofrontera) for use in combination with a narrowband red light photodynamic therapy (PDT) lamp (BF-RhodoLED) for treatment of actinic keratoses (AKs) of mild to moderate severity on the face and scalp. A 20% ALA solution (Levulan Kerastick) approved for use in combination with blue light PDT (BLU-U) has been available in the US since 2002.

Capsaicin, a vanillyl alkaloid found in hot peppers and related plants, is now available without a prescription as Zostrix-HP (GenDerm) for topical relief of pain due to diabetic neuropathy, herpes zoster, or arthritis. The new formulation contains 0.075% capsaicin; the drug was previously available in a 0.025% concentration as Zostrix.

The FDA has approved the selective alpha₂-adrenergic receptor agonist brimonidine as a 0.33% gel (Mirvaso – Galderma) for topical treatment of adults with persistent facial erythema of rosacea. Brimonidine is also available in ophthalmic formulations for treatment of glaucoma.