Actavis Pharma, Inc
The FDA has approved Delzicol (mesalamine) delayed-release capsules to treat mildly to moderately active ulcerative colitis (UC) in patients 12 years and older. The recommended dosage for adults is two 400-mg capsules 3 times a day, at least 1 hour before or 2 hours after a meal, for a total daily dose of 2.4 g for 6 weeks. In patients 12 years and older, the total daily dose is weight-based (maximum: 2.4 g/day); dosing is twice daily for 6 weeks at least 1 hour before or 2 hours after a meal. Delzicol is also indicated for the maintenance of remission of UC in adults.
Delayed-release capsules: 400 mg
For More Information: www.delzicol.com
Levemir FlexTouch, a prefilled insulin-delivery device, has been FDA approved for glycemic control in adults and children with diabetes mellitus. The starting dose should be individualized based on the type of diabetes and whether the patient is insulin-naïve. The recommended administration is subcutaneously once daily or in divided doses twice daily. Once-daily administration should be given with the evening meal or at bedtime. Levemir (insulin detemir injection) is not recommended for the treatment of diabetic ketoacidosis.
Solution for injection: 100 U/mL
For More Information: www.levemirpro. com/prescribing/levemir-flextouch.html
Merck & Co, Inc
The FDA has approved Grastek (Timothy grass pollen allergen extract) for the treatment of grass pollen–induced allergic rhinitis, with or without conjunctivitis, that has been confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. The recommended dosage is 1 tablet daily. The tablet should be placed under the tongue and allowed to remain there until it completely dissolves; patients should not swallow for at least 1 minute.
Tablets for sublingual use: 2800 bioequivalent allergy units
For More Information: www.grastek.com
The FDA has approved Sivextro (tedizolid phosphate), an oxazolidinone- class antibacterial drug, for the treatment of acute bacterial skin and skin structure infections caused by designated susceptible bacteria. The recommended dosage is 200 mg once daily by mouth or as an intravenous infusion over 1 hour for 6 days. Sivextro should be used only to treat or prevent infections that are proved, or strongly suspected, to be caused by bacteria.
Lyophilized powder in a single-use vial for reconstitution for intravenous infusion: 200 mg;
For More Information: www.sivextro.com