The FDA has approved daclizumab (Zinbryta – Biogen/Abbvie), an interleukin-2 (IL-2) receptor blocking monoclonal antibody, for treatment of adults with relapsing forms of multiple sclerosis (MS). It is the first subcutaneously injected monoclonal antibody to be approved for treatment of MS.

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...

Acute cough (<3 weeks in duration) generally does not require pharmacologic treatment, especially in children. Suppression of productive cough may be harmful. Management of patients with cough should include elimination of any precipitating factor (e.g., cigarette smoking) and treatment of any underlying cause such as upper airway cough syndrome, gastroesophageal reflux disease, asthma, or other pulmonary disease.

Sitagliptin (Januvia) and metformin (Glucophage, and others) are now available in a single tablet (Janumet - Merck) for treatment of type 2 diabetes. The combination is approved by the FDA for use in patients not adequately controlled by sitagliptin or meformin alone or in those already taking both drugs. Metformin is also available in combination with the thiazolidinediones pioglitazone and rosiglitazone and with the sulfonylureas glipizide and glyburide.

The FDA has approved the marketing of Resperate (InterCure), a device that helps patients breathe slowly, as an adjunct for treatment of hypertension. The FDA does not require proof of effectiveness for approval of devices with minimal potential for harm, such as this one.

The FDA has approved Viekira Pak (Abbvie), a fixed-dose combination of two new direct-acting antiviral agents (ombitasvir, paritaprevir) with the pharmacologic enhancer ritonavir in one tablet, co-packaged with a third new direct-acting antiviral agent (dasabuvir) in a second tablet, for oral treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US.

The FDA has approved ocrelizumab (Ocrevus – Genentech), a humanized anti-CD20 monoclonal antibody, for treatment of adults with primary progressive or relapsing multiple sclerosis (MS). It is the first anti-CD20 monoclonal antibody to be approved for treatment of MS and the first disease-modifying drug to be approved in the US for primary progressive MS.

The FDA has approved ozanimod (Zeposia – Celgene), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). It is the third oral S1P receptor modulator to be approved in the US for treatment of relapsing forms of MS; siponimod (Mayzent) is also indicated for use in adults, and fingolimod (Gilenya) is approved for use in patients ≥10 years old.

The FDA has approved nivolumab (Opdivo – BMS), an IV programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (and a BRAF inhibitor in patients who are BRAF V600 mutation positive) and for treatment of metastatic squamous non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy. It is the second PD-1 inhibitor to be marketed in the US after pembrolizumab (Keytruda), and the first to be approved for treatment of NSCLC.

Arformoterol tartrate (Brovana - Sepracor), a singleisomer, long-acting beta₂-agonist, has been approved by the FDA as an inhalation solution for nebulization for treatment of bronchoconstriction pulmonary disease (COPD). Arformoterol is the (R,R)-enantiomer of formoterol (Foradil), which is available as a powder for inhalation and was recently also approved as a solution for nebulization (Perforomist - Dey; available fall 2007)