The FDA recently approved the proton pump inhibitor omeprazole magnesium (Prilosec OTC) for over-the-counter use for treatment of frequent heartburn. It will be marketed in late September or early October. Five proton pump inhibitors, including omeprazole, are available by prescription in the US (Medical Letter 2001; 43:36).

The fixed-dose combination of olanzapine and fluoxetine (Symbyax - Lilly) has been approved by the FDA for treatment of depressive episodes associated with bipolar disorder. Olanzapine alone (Zyprexa), which is mainly used as an antipsychotic (Medical Letter 2003; 45:102), is FDA-approved for treatment of acute manic episodes and for maintenance treatment of bipolar disorder. Fluoxetine alone (Prozac, and others), which is mainly used as an antidepressant (Medical Letter 2003; 45:93), has no specific approval for use in bipolar...

Inhaled drugs for asthma are available in the US mainly in pressurized metered-dose inhalers (MDIs), which require a propellant, and dry powder inhalers, which do not. The chlorofluorocarbon (CFC) propellants in MDIs are being replaced by hydrofluoroalkane (HFA) propellants for environmental reasons: CFCs contribute to the depletion of the ozone layer. December 31, 2008 will be the last day that albuterol MDIs using CFC propellants can be sold in the US. The FDA is expected to announce a termination date for other CFC-containing products in the near future.Three HFA albuterol inhalers and one...

Gabapentin enacarbil (Horizant – GlaxoSmithKline), a new extended-release (ER) tablet formulation of gabapentin, has been approved by the FDA for treatment of moderate-to-severe restless legs syndrome (RLS). The immediate-release (IR) formulation of gabapentin (Neurontin,and others), which is approved for treatment of epilepsy and postherpetic neuralgia, has been used for many years to treat RLS. Another ER tablet formulation of gabapentin (Gralise) has been approved by the FDA for treatment of postherpetic neuralgia.

The FDA has approved Duexis (Horizon), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the H2-receptor antagonist (H2RA) famotidine, for symptomatic relief of osteoarthritis and rheumatoid arthritis and to decrease the risk of developing gastric and duodenal ulcers in patients at risk for NSAID-associated ulcers. Vimovo, a combination of the NSAID naproxen and the proton pump inhibitor (PPI) esomeprazole, is also approved by the FDA for prevention of NSAID-associated gastric ulcers.

The FDA has approved the antiparasitic drug ivermectin in a 0.5% lotion (Sklice – Sanofi Pasteur) as a single-use topical treatment for head lice in patients ≥6 months old. Oral ivermectin (Stromectol – Merck) is effective for treatment of head lice resistant to other therapies, but it has not been approved by the FDA for this indication.

The FDA has approved raxibacumab (rax” ee bak’ ue mab; GSK), a fully human monoclonal antibody given by intravenous infusion, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. It was approved under the Animal Efficacy Rule, which allows the FDA to approve drugs that demonstrate efficacy in animals, providing that they would have a reasonable human health benefit and are safe for human use. Raxibacumab is only available from the...

The FDA has approved the melatonin receptor agonist tasimelteon (Hetlioz – Vanda) for treatment of non-24-hour sleep-wake disorder (non-24), which is common in totally blind persons. Tasimelteon is the first drug approved for this indication and the second melatonin receptor agonist approved for use in the US; ramelteon (Rozerem) was approved earlier for treatment of insomnia. Melatonin itself has not been approved by the FDA for any indication; it is available in the US as a dietary supplement and is promoted as a sleep aid.

The FDA has announced that it is requiring changes in the labeling of systemic fluoroquinolones to warn that the risk of serious adverse effects, including tendinitis, peripheral neuropathy and CNS effects, generally outweighs their benefit for the treatment of acute sinusitis, acute exacerbations of chronic bronchitis, and uncomplicated urinary tract infections. For these infections, the new labels will recommend reserving fluoroquinolones for patients with no other treatment options.

The nasal spray formulation of the corticosteroid fluticasone furoate is now available over the counter (OTC) as Flonase Sensimist Allergy Relief (GSK) in the same strength as the prescription product (Veramyst) for treatment of seasonal or perennial allergic rhinitis. It is the fourth intranasal corticosteroid to become available OTC.