Ranbaxy Laboratories Inc
Ranbaxy Laboratories Inc has launched Absorica capsules (isotretinoin), which are indicated for the treatment of severe recalcitrant nodular acne in patients 12 years and older. The recommended dosage is 0.5 to 1 mg/ kg/day given in 2 divided doses without regard for meals. Absorica must not be used by female patients who are or may become pregnant while taking the drug, due to an extremely high risk of severe birth defects.
Capsules: 10, 20, 30, and 40 mg
For More Information: www.ranbaxyusa.com
The FDA has approved an expanded use of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in older children and adolescents aged 6 through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. For this age group it is given as a single dose in treatment-naive patients.
Intramuscular injection: 0.5-mL suspension supplied in a single-dose prefilled syringe
For More Information: www.prevnar.com
Expanded use of Gleevec (imatinib mesylate) tablets to treat newly diagnosed pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase has been approved by the FDA. The dose indicated for pediatric patients is 340 mg/m2/day. Doses of Gleevec should be taken with a meal and a large glass of water. The medication may be dissolved in water or apple juice for patients who are having difficulty swallowing.
Tablets (scored): 100, 400 mg
For More Information: www.gleevec.com
Bayer HealthCare Pharmaceuticals
The FDA has expanded the approved use of Stivarga (regorafenib) to treat patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. It carries a boxed warning on hepatotoxicity that recommends the monitoring of hepatic function prior to and during treatment. The recommended dose is 160 mg orally with a low-fat breakfast once daily for the first 21 days of each 28-day cycle.
40-mg film-coated tablets
For More Information: www.stivarga-us.com