Rx Product News

Astellas Pharma US, Inc

Indication: The FDA has approved Astagraf XL (tacrolimus extended-release capsules), a calcineurin-inhibitor immunosuppressant, for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil and corticosteroids, with or without basiliximab induction. The recommended dose with basiliximab induction is 0.15 mg/kg/day. Without basiliximab induction, the preoperative dose is 0.1 mg/kg/day and the postoperative dose is 0.2 mg/kg/day. Astagraf XL is not interchangeable with tacrolimus immediate-release capsules and should not be used simultaneously with cyclosporine.

Dosage Form: Capsules: 0.5, 1, and 5 mg

For More Information: www.astellas.us/docs/AstagrafXL.pdf

Shionogi, Inc

Indication: The FDA has approved Osphena (ospemifene), an estrogen agonist/antagonist, for the treatment of moderate to severe dyspareunia—a symptom of vulvar and vaginal atrophy—due to menopause. The recommended dose of Osphena is 1 tablet orally once daily with food. Osphena should not be used concomitantly with estrogens or estrogen agonist/antagonists, fluconazole, or rifampin.

Dosage Form: Tablets: 60 mg

For More Information: www.osphena.com

Salix Pharmaceuticals, Inc

Indication: The FDA has approved Giazo (balsalazide disodium), a locally acting aminosalicylate, for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years and older. The recommended dose is three 1.1-g tablets 2 times a day (6.6 g/day) with or without food for up to 8 weeks.

Dosage Form: Tablets: 1.1 g

For More Information: www.giazo.com

Janssen Therapeutics

Indication: The FDA has approved Sirturo (bedaquiline), a diarylquinoline antimycobacterial, for combination therapy in adults 18 years and older with pulmonary multidrug-resistant tuberculosis. The drug is not indicated for the treatment of latent, extrapulmonary, or drug-sensitive tuberculosis. The recommended dose is 400 mg once daily for 2 weeks, followed by 200 mg 3 times per week for 22 weeks. The tablets should be taken with food and swallowed whole with water.

Dosage Form: Tablets: 100 mg

For More Information: www.sirturo.com