Testosterone is now available in a 1% gel (AndroGel - Unimed) for treatment of hypogonadism in men. AndroGel, which is rubbed on the skin, is the fourth transdermal preparation of testosterone to be marketed in the USA.

Fluticasone propionate, an inhaled corticosteroid, and salmeterol xinafoate, a long-acting beta2-adrenergic agonist, are now available together in a dry-powder inhaler for maintenance treatment of patients with asthma. The new combination is not recommended for treatment of acute bronchospasm or for treatment of children less than 12 years old.

A recent supplement to the Journal of Clinical Psychiatry, titled "The Expert Consensus Guideline Series: Optimizing Pharmacologic Treatment of Psychotic Disorders," concluded that most experts endorsed use of second-generation (atypical) antipsychotics rather than first-generation drugs, with risperidone (Risperdal - Janssen) the top choice for first episodes, multiple episodes or switches from another drug (JM Kane et al, J Clin Psychiatry 2003; 64 suppl 12:5). The supplement was sponsored by Janssen.

A combination tablet containing estradiol and drospirenone (Angeliq - Berlex) recently became available for treatment of moderate to severe menopausal symptoms in women with an intact uterus. Since the last Medical Letter issue reviewing such devices,1 more continuous glucose monitoring (CGM) systems have become available. Five devices available now, and two expected to be marketed soon, are listed in the table on page 14. The FDA has approved continuous glucose devices only for the observation of glucose trends.

Chemotherapy can result in premature menopause and infertility in young women. Pretreatment fertility counseling followed by appropriate action may prevent some of these undesirable consequences.

The FDA has approved an intranasal gel formulation of testosterone (Natesto – Trimel/Endo) for replacement therapy in men with hypogonadism. Packaged in a metered-dose pump, Natesto is the first intranasal testosterone to become available in the US. Like other testosterone products, it is classified as a schedule III controlled substance. The FDA recently cautioned against using testosterone to treat low testosterone levels solely due to aging because the benefits and safety of such use have not been established, and there is a possible increased risk of myocardial infarction...

The FDA has approved elagolix (Orilissa – AbbVie), an oral gonadotropin-releasing hormone (GnRH) antagonist, for management of moderate to severe pain associated with endometriosis.

The FDA has approved Dovato (ViiV), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, and generics), as a once-daily complete regimen for treatment of adults with HIV-1 infection who are antiretroviral-treatment naive and have no known substitutions associated with resistance to either drug. Dolutegravir/lamivudine is the first complete regimen to be approved by the FDA for initial treatment of HIV-1 infection that contains 2 rather than 3 antiretroviral...

Oriahnn (Abbvie), a fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist elagolix, the estrogen estradiol, and the progestin norethindrone acetate copackaged with elagolix alone, has been approved by the FDA for oral treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the first product to be approved in the US for this indication. Elagolix (Orilissa) has been available since 2018 for treatment of moderate to severe pain associated with endometriosis. The GnRH receptor antagonist...

Myfembree (Myovant/Pfizer), an oral fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix, the estrogen estradiol, and the progestin norethindrone acetate, has been approved by the FDA for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the second product to be approved in the US for this indication; Oriahnn, which contains the GnRH receptor antagonist elagolix in combination with estradiol and norethindrone acetate, was approved earlier. Relugolix was approved for...