Saxagliptin (Onglyza - Bristol-Myers Squibb), the second oral dipeptidyl peptidase-4 (DPP-4) inhibitor to be marketed in the US, has been approved by the FDA for treatment of adults with type 2 diabetes.

The FDA has approved use of tadalafil (Adcirca - Lilly/United Therapeutics) for treatment of pulmonary arterial hypertension (PAH).

Paliperidone palmitate (Invega Sustenna – Ortho-McNeil Janssen) has been approved by the FDA as a once-monthly injection for acute and maintenance treatment of schizophrenia in adults. An extended-release oral formulation (Invega) has been available since 2006.1 Long-acting injections of antipsychotic drugs typically are used to treat patients who cannot adhere to an oral regimen.2,3 Paliperidone is the primary active metabolite of risperidone (Risperdal), which is also available as a long-acting (every 2 weeks) injection. It is unclear whether either risperidone or paliperidone is a better choice for long-term treatment of schizophrenia than a first-generation drug such as haloperidol, which can also be injected once a month and costs much less.4

1. Paliperidone (Invega) for schizophrenia. Med Lett Drugs Ther 2007; 49:21.
2. JC West et al. Use of depot antipsychotic medications for medication non-adherence in schizophrenia. Schizophr Bull 2008; 34:995.
3. D Hough et al. Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry 2009; 33:1022.
4. Drugs for psychiatric disorders. Treat Guidel Med Lett 2006; 4:35.

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In 2007, Merck voluntarily recalled some lots of PedvaxHIB and Comvax, two Haemophilus influenzae type b (Hib) vaccines, and temporarily stopped their production because of possible contamination, resulting in a shortage during which pediatricians were urged to defer giving Hib booster doses (normally given at 12-15 months) to healthy children. Now the FDA has granted accelerated licensure of Hiberix (GlaxoSmithKline), a monovalent vaccine conjugated with tetanus toxoid that has been used in Europe since 1996, as a booster (final) dose of the Hib series in children 15 months-4 years old. Hiberix can also be given to children 12-15 months old as a scheduled booster dose.1

1. Licensure of a Haemophilus influenzae type b (Hib) vaccine (Hiberix) and updated recommendations for use of Hib vaccine. MMWR Morb Mortal Wkly Rep 2009; 58:1008.

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