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.

The FDA recently announced that it was investigating 38 reports of loss of vision in men who took sildenafil (Viagra), which has been used to treat erectile dysfunction since 1998.

An intraveneous (IV) formulation of ibuprofen (Caldolor - Cumberland) was recently approved by the FDA for use in adults. It can be administered alone for treatment of mild to moderate pain or as an adjunct to opioid analgesics for moderate to severe pain. It is also approved for reduction of fever.

The FDA has approved macitentan (ma" si ten' tan; Opsumit – Actelion), for oral treatment of pulmonary arterial hypertension (PAH). Macitentan is the second nonselective endothelin receptor antagonist approved for PAH. It is a derivative of bosentan (Tracleer), which is also manufactured by Actelion, and is scheduled to become available generically in 2015. Riociguat (Adempas), another new drug for this indication, will be reviewed in a future issue. Volibris

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 now approved a recombinant, 9-valent, human papillomavirus (HPV) vaccine (Gardasil 9 – Merck) for use in girls and women 9-26 years old and boys 9-15 years old. The new vaccine is indicated to prevent diseases associated with infection with HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, which include genital warts and cervical, vulvar, vaginal, and anal precancerous lesions and cancer. Two recombinant HPV vaccines are already available in the US: Gardasil prevents disease associated with HPV types 6, 11, 16, and 18, and Cervarix prevents disease associated with HPV...

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.

The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal. It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy.

The FDA has approved a manually injected, single-dose, prefilled epinephrine syringe (Symjepi – Adamis/Sandoz) for emergency treatment of anaphylaxis. The new device is approved in 0.3- and 0.15-mg strengths for treatment of patients weighing ≥30 kg and 15 to 30 kg, respectively; only the 0.3-mg strength is currently available. According to Sandoz, Symjepi will be made available first to institutions and later to the retail market.

The FDA has approved a higher-dose intranasal naloxone formulation (Kloxxado – Hikma) for emergency treatment of opioid overdose. A single spray of the new formulation delivers 8 mg of naloxone; a formulation that delivers 4 mg per spray (Narcan) was approved in 2015.