The FDA has approved the marketing of desvenlafaxine (Pristiq - Wyeth), the main active metabolite of venlafaxine (Effexor, and others - Wyeth), for treatment of major depressive disorder. Venlafaxine, a norepinephrine and serotonin reuptake inhibitor (SNRI), is available generically as an immediate-release tablet. Venlafaxine extended-release capsules (Effexor XR) are scheduled to go off-patent in 2010.

The FDA has approved cannabidiol oral solution (Epidiolex – Greenwich Biosciences) for treatment of seizures associated with Dravet syndrome or Lennox-Gastaut syndrome in patients ≥2 years old. Cannabidiol (CBD) is a cannabinoid constituent of the marijuana plant (Cannabis sativa). It is the first natural marijuana product to be approved by the FDA for any indication and the first drug to be approved in the US for treatment of Dravet syndrome. Stiripentol (Diacomit), which is not a marijuana product, was also recently approved by the FDA for treatment of Dravet syndrome in...

The FDA has approved three new once-daily fixed-dose antiretroviral drug combinations for treatment of HIV-1 infection. Symfi and Symfi Lo (Mylan) contain the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz and the nucleoside reverse transcriptase inhibitors (NRTIs) lamivudine and tenofovir disoproxil fumarate (TDF) and were approved as complete antiretroviral regimens. Symfi Lo contains a lower dose of efavirenz than both Symfi and Atripla, a fixed-dose combination of efavirenz, TDF, and the NRTI emtricitabine that was approved in 2006. Cimduo (Mylan), which...

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...

The FDA has approved a new tablet formulation of immediate-release (IR) oxycodone (Oxecta – King) for management of acute and chronic moderate to severe pain.Oxecta uses a tamper-resistant technology designed to deter oxycodone abuse by injection or nasal snorting. Dissolving the crushed tablet in water or alcohol converts it into a viscous gel mixture, making it difficult to inject. Crushing the tablet and inhaling it through the nose causes burning and irritation. Whether the new formulation will actually prevent abuse of the drug has not been established. Oxecta is classified as a...

Some readers of our article on Antiviral Drugs for Seasonal Influenza have expressed concerns regarding our recommendation for use of the oral neuraminidase inhibitor oseltamivir (Tamiflu) to treat high-risk patients with confirmed or suspected influenza illness, citing the British Medical Journal and The Cochrane Collaboration, which have contended that there is no acceptable evidence that the drug prevents complications or hospitalizations and have questioned the completeness of the results of controlled trials conducted by the manufacturer (Roche).

Nafarelin acetate (Synarel - Syntex), a synthetic analog of gonadotropin-releasing hormone (GnRH), was recently approved by the US Food and Drug Administration for treatment of endometriosis. The drug is available only in a nasal spray formulation.

Tacrine hydrochloride (Cognex - Parke-Davis), an acridinamine derivative, will soon be available for treatment of cognitive deficits associated with Alzheimer's disease.

Venlafaxine hydrochloride (Effexor - Wyeth-Ayerst) was recently approved by the US Food and Drug Administration for treatment of depression. An aminomethyl-benzyl- cyclohexanol, it is chemically related to bupropion (Wellbutrin).