Duetact (Takeda), a new fixed-dose combination of the thiazolidinedione pioglitazone (Actos) and the sulfonylurea glimepiride (Amaryl, and others), was recently approved by the FDA for treatment of type 2 diabetes. It is approved as an adjunct to diet and exercise to improve glycemic control in patients already taking pioglitazone and/or a sulfonylurea. Avandaryl, a combination of glimepiride and the thiazolidinedione rosiglitazone, was approved in 2006.

Tinidazole (Tindamax - Mission Pharmacal), an oral antiprotozoal drug available in the US since 2004 for treatment of trichomoniasis, giardiasis, amebiasis and amebic liver abscess, was recently approved by the FDA for treatment of bacterial vaginosis.

The FDA has approved the use of ustekinumab (Stelara - Centocor Ortho Biotech), an interleukin antagonist given by subcutaneous (SC) injection for treatment of adults with moderate to severe plaque psoriasis. It is the first agent in its class for this indication; the other biologic agents for psoriasis are Tcell or tumor necrosis factor (TNF) inhibitors.

The FDA has approved Apadaz (KemPharm), a short-acting, fixed-dose combination of benzhydrocodone and acetaminophen, for short-term management (≤14 days) of acute pain severe enough to require an opioid and for which alternative treatment options are inadequate. Benzhydrocodone is a prodrug of hydrocodone. Fixed-dose combinations of short-acting hydrocodone and acetaminophen or ibuprofen have been available for years and are the most abused opioid products in the US. Apadaz was developed under the presumption that inclusion of the inactive prodrug would reduce the potential for...

Tigecycline (Tygacil - Wyeth), a derivative of minocycline, is a new intravenous (IV) antibiotic approved for treatment of complicated intra-abdominal and skin and skin-structure infections.

The FDA has approved the marketing of fesoterodine (Toviaz - Pfizer), a muscarinic receptor antagonist, for treatment of overactive bladder. It is the sixth antimuscarinic drug approved for this indication.

Golimumab (Simponi - Centocor), a fully humanized anti-tumor necrosis factor (TNF)-a antibody, has been approved by the FDA for the treatment of: (1) moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate; (2) active psoriatic arthritis (PsA) alone or in combination with methotrexate; and (3) active ankylosing spondylitis (AS).

The FDA has approved tapentadol hydrochloride (Nucynta - Ortho-McNeil Janssen) for oral treatment of moderate to severe acute pain in patients ≥18 years old. It has been classified as a Schedule II controlled substance

The FDA has approved stiripentol (Diacomit – Biocodex) for treatment of seizures in patients ≥2 years old with Dravet syndrome who are also taking clobazam (Onfi). Stiripentol, which has been available in Europe, Canada, and Japan for many years, is the second drug to be approved in the US for this indication; cannabidiol oral solution (Epidiolex), a purified marijuana product, was the first.

Rozanolixizumab-noli (Rystiggo – UCB), a neonatal Fc receptor (FcRn) blocker, has been approved by the FDA for treatment of generalized myasthenia gravis in adults with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. It is the first drug to be approved for treatment of generalized myasthenia gravis in patients with anti-MuSK antibodies. Four other biologic drugs – the FcRn blocker efgartigimod alfa (Vyvgart; Vyvgart Hytrulo) and the complement inhibitors eculizumab (Soliris), ravulizumab (Ultomiris), and zilucoplan (Zilbrysq) – are...