Femcon Fe (Warner Chilcott) is being advertised as the world's only chewable oral contraceptive. It was formerly marketed as Ovcon 35 Fe. Each packet provides 21 tablets containing 0.4 mg norethindrone and 35 mcg ethinyl estradiol, and 7 tablets with only 75 mg of ferrous fumarate. Femcon Fe has the same active hormonal ingredients as Ovcon 35 (Warner Chilcott), which has been available since 1976, and its generic equivalent Balziva (Barr); neither formulation contains iron. The spearmint-flavored Femcon Fe pill can be chewed or swallowed whole. According to the package labeling, if the pill...

The FDA has approved a 5% ophthalmic solution of lifitegrast (Xiidra – Shire), a lymphocyte function-associated antigen-1 (LFA-1) antagonist, for treatment of the signs and symptoms of dry eye disease. Lifitegrast is the first LFA-1 antagonist to be approved for any indication in the US.

Primary hypothyroidism is usually the result of Hashimoto's (autoimmune) thyroiditis, thyroidectomy, or radioactive iodine therapy. Treatment of hypothyroidism with replacement doses of thyroid hormone is usually lifelong. Levothyroxine (LT4; synthetic thyroxine; Synthroid, and others) is the drug of choice.1

Two new formulations of existing drugs were recently approved by the FDA for treatment of male androgenetic alopecia. Finasteride, a steroid 5alpha-reductase inhibitor previously marketed in a 5-mg tablet as Proscar for treatment of benign prostatic hyperplasia (Medical Letter, 34:83, 1992), has now been approved in a 1-mg tablet as Propecia (Merck) for oral treatment of men with male pattern hair loss. Minoxidil, a peripheral vasodilator used to treat hypertension, was previously available over the counter in a 2% topical solution (Rogaine, and others) for treatment of androgenetic alopecia...

Teriparatide (ter i par' a tide; Forteo - Lilly), a recombinant segment of human parathyroid hormone, has been approved by the FDA for parenteral treatment of osteoporosis in post-menopausal women, and in men with idiopathic or hypogonadal osteoporosis, who are at high risk for fracture. Teriparatide is the first approved treatment for osteoporosis that stimulates bone formation. Other drugs approved for this indication inhibit bone resorption (Treatment Guidelines from the Medical Letter 2002;1:13).

The FDA has approved the use of tranexamic acid (Lysteda – Ferring), an oral antifibrinolytic, for treatment of menorrhagia. Tranexamic acid has been used for this purpose in Europe for decades, and is available without a prescription in some countries. It has been available in the US since 1987 for use with coagulation factors in patients with hemophilia undergoing dental extractions.

Armodafinil (Nuvigil – Cephalon), the R-enantiomer of the non-amphetamine stimulant modafinil (Provigil – Cephalon; Alertec – Shire in Canada), is being promoted directly to the public for treatment of excessive daytime sleepiness associated with shift work.

The FDA has approved secnidazole oral granules (Solosec – Symbiomix/Lupin) for single-dose treatment of bacterial vaginosis (BV) in adult women.

The FDA has approved sacituzumab govitecan-hziy (Trodelvy – Immunomedics), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease. It is the first Trop-2-directed antibody-drug conjugate to become available in the US.

The FDA has approved suzetrigine (Journavx – Vertex), a selective sodium channel blocker, for oral treatment of moderate to severe acute pain in adults. Suzetrigine is the first sodium channel blocker to be approved in the US for this indication and the first oral nonopioid drug to be approved for treatment of pain in over 25 years.