The FDA has announced the approval of Tecfidera (dimethyl fumarate) delayed-release capsules for the treatment of adult patients with relapsing forms of multiple sclerosis. The recommended starting dose is 120 mg taken orally twice a day for 7 days, with a maintenance dose after 7 days of 240 mg twice a day. The capsules should be swallowed whole and intact and not crushed or chewed. Tecfidera may be taken with or without food.
Delayed-release capsules: 120 and 240 mg
For More Information: www.tecfidera.com
Iclusig (ponatinib) tablets have been approved by the FDA for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig is a kinase inhibitor that is indicated for use in patients whose leukemia is resistant or intolerant to prior tyrosine kinase inhibitor therapy. The recommended dosage is 45 mg taken orally once daily with or without food.
Tablets: 15 and 45 mg
For More Information: www.iclusig.com
The FDA has approved TOBI Podhaler (tobramycin inhalation powder), an antibacterial aminoglycoside indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa
. The TOBI Podhaler is a plastic, handheld inhaler device for use with TOBI Podhaler capsules, which contain tobramycin dry powder for inhalation. The recommended dose is four 28-mg capsules inhaled twice daily for 28 days. Capsules are for oral inhalation only and should not be swallowed.
Inhalation powder: 28 mg in a capsule
For More Information: www.novartis.com
Protein Sciences Corporation
The FDA has approved Flublok (influenza vaccine), indicated for active immunization against disease caused by influenza virus subtypes A and type B. Flublok does not use the influenza virus or eggs in its production and is made using an insect virus expression system and recombinant DNA technology. It is approved for use in adults aged 18 through 49 years. The recommended dose is a single 0.5-mL intramuscular injection.
Sterile solution for injection in a single-dose vial: 0.5 mL
For More Information: www.flublok.com