Pentosan polysulfate sodium (Elmiron - Baker Norton), a semi-synthetic mucopolysaccharide structurally similar to heparin, has been approved by the US Food and Drug Administration for oral treatment of interstitial cystitis.

On February 9, 2005, Health Canada suspended the marketing of Adderall XR (Shire), a mixture of amphetamine salts used to treat attention-deficit hyperactivity disorder (ADHD) (Med Lett Drugs Ther 1994; 36:109). The immediate-release form of Adderall was never marketed in Canada. The withdrawal was based on 20 reports internationally of sudden death in patients taking the drug. These deaths, 14 of them in children, were not linked to overdose or abuse. The FDA decided that the number of sudden deaths was no greater than expected among the large number of people taking the drug, but because 5...

The FDA has approved Technivie (Abbvie), a fixed-dose combination of the direct-acting antiviral agents ombitasvir and paritaprevir and the pharmacokinetic enhancer ritonavir, for oral treatment of chronic hepatitis C virus (HCV) genotype 4 infection in patients without cirrhosis. It is indicated for use in combination with ribavirin. Ombitasvir/paritaprevir/ritonavir copackaged with dasabuvir, an HCV RNA polymerase inhibitor that has little activity against HCV genotype 4, is approved as Viekira Pak for treatment of HCV genotype 1 infection.1HCV genotype 4 is uncommon in the US and Canada. It...

The FDA has approved the use of subcutaneous injections of deoxycholic acid (Kybella – Kythera/Allergan) to improve the appearance of moderate to severe convexity or fullness associated with submental fat (double chin) in adults. It is the first drug approved for this indication.

Methylphenidate (Ritalin and others), a Schedule II controlled substance in the USA, is a short-acting central-nervous-system stimulant widely used for treatment of children with school performance or behavior problems, or what is now called Attention Deficit-Hyperactivity Disorder, or AD-HD (American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, third ed., revised [DSM-III R], Washington, DC:authors, 1987, p 50). Some studies have estimated that more than 3% of elementary school students are taking methylphenidate, and one parents' group has brought a...

Flosequinan (Manoplax - Boots), a fluoroquinolone derivative, is now available in the USA for treatment of congestive heart failure. Labeling approved by the US Food and Drug Administration recommends the drug only for patients who cannot tolerate or have not responded adequately to an angiotensin-converting enzyme (ACE) inhibitor.

Nedocromil sodium (Tilade - Fisons), an anti-inflammatory drug similar to cromolyn sodium (Intal - Fisons), although chemically unrelated, is now available in the USA as a metered-dose inhaler for maintenance treatment of mild to moderate asthma.

Risperidone (Risperdal - Janssen), a benzisoxazole derivative, is now available in the USA for treatment of schizophrenia and other psychotic disorders.

Cetirizine (Zyrtec, and others) and cetirizine/pseudoephedrine (Zyrtec-D) are becoming available without a prescription this month for treatment of allergic rhinitis and urticaria in adults and children. Cetirizine is the second of the second-generation H1-antihistamines to become available over the counter. Loratadine (Claritin, and others) was the first.Cetirizine has been shown to be more effective than loratadine in suppressing histamine-induced wheals in healthy volunteers (W Carey et al. Drugs Exp Clin Res 2002; 28:243), but no well-controlled clinical trials have established that any...

The FDA has approved ivacaftor (eye va kaf’ tor; Kalydeco – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥6 years old with the G551D mutation, which is found in about 5% of patients with CF. It is the first drug approved in the US that treats the cause of the disease.