The FDA has approved prasugrel (Effient - Lilly/Daiichi Sankyo), an oral antiplatelet drug, for use with aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention (PCI). It will compete with clopidogrel (Plavix) for such use.

On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of a booster dose ≥6 months after a 2-dose primary series in adults who are ≥65 years old or at high risk for severe COVID-19 because of an underlying medical condition or frequent institutional or occupational exposure to SARS-CoV-2 (see Table 1). The FDA Advisory Committee recommended against authorization of a booster dose of Comirnaty...

The FDA has approved inclisiran (Leqvio – Novartis), a small interfering RNA (siRNA) directed to proprotein convertase subtilisin/kexin type 9 (PCSK9) mRNA, as an adjunct to diet and maximally tolerated statin therapy for subcutaneous (SC) treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Inclisiran is the first FDA-approved PCSK9-directed siRNA therapeutic agent.

Oral antipsychotic drugs used for treatment of schizophrenia, schizoaffective disorder, delusional disorder, and other manifestations of psychosis or mania are listed in Table 1. Parenteral antipsychotic drugs used for treatment of these disorders are listed in Table 2.

Dehydroepiandrosterone (DHEA), an endogenous adrenal steroid, is marketed as a dietary supplement in the US. It is widely promoted to reverse the effects of aging (loss of muscle, memory and libido) and has been used by athletes as a substitute for anabolic steroids. DHEA is banned by the International Olympic Committee, National Collegiate Athletic Association, National Football League and other sports organizations, but it was specifically exempted from becoming a controlled substance in the Anabolic Steroid Control Act of 2004.

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.

Nabilone, an oral synthetic cannabinoid similar to delta-9-tetrahydrocannabinol (THC), the active ingredient in marijuana, has recently been reintroduced to the US market (Cesamet - Valeant) after a 17-year absence. The previous manufacturer discontinued marketing of the drug for commercial reasons. Nabilone is classified as a Schedule II controlled substance.

Pregabalin (Lyrica - Pfizer) is the first drug approved by the FDA for management of fibromyalgia. When it was first marketed, pregabalin, which is structurally similar to gabapentin (Neurontin, and others), was approved for treatment of neuropathic pain associated with postherpetic neuralgia and diabetic peripheral neuropathy and for adjunctive treatment of partial onset seizures in adults with epilepsy. It has also been prescribed off-label for other types of neuropathic pain such as sciatica.

The FDA has licensed 4 new monovalent vaccines for prevention of respiratory illness caused by a new influenza A H1N1 virus that appears to be derived from a swine strain. The 5th vaccine should be licensed soon. All of these vaccines are expected to become available in October. An intranasal formulation is expected in the first week of October.

The FDA has approved the marketing of iloperidone (Fanapt – Vanda), a second-generation antipsychotic, for treatment of schizophrenia. Iloperidone is chemically related to risperidone (Risperdal, and others).