Jane S. Ricciuti, RPh, MS


January 23, 2004

In This Article

Gastrointestinal Agents

(orlistat) Capsules

Manufacturer: Hoffmann-La Roche

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 12/12/03)

New Indication: This supplemental new drug application provides for revised labeling to provide for use of Xenical (orlistat) in the management of obesity in adolescent patients aged 12-16 years.


Xenical (orlistat) Capsules Labeling

Xenical (orlistat) Capsules

Zorbtive (somatropin [rDNA origin]) for Injection

Manufacturer: Serono, Inc.

Drug Approval Classification: Original New Drug Application (Approval Date: 02/03/03)

Indication: Zorbtive (somatropin [rDNA origin]) for Injection is indicated for the treatment of short bowel syndrome (SBS) in patients receiving specialized nutritional support. Specialized nutritional support may consist of a high-carbohydrate, low-fat diet, adjusted for individual patient requirements and preferences.

Dosing: Zorbtive should be administered to patients with SBS at a dose of approximately 0.1 mg/kg subcutaneously daily to a maximum of 8 mg daily. Administration for more than 4 weeks has not been adequately studied. Injections should be administered daily for 4 weeks.

Clinical Summary: Zorbtive is a human growth hormone (hGH) produced by recombinant DNA technology. In patients with SBS, Zorbtive is believed to have an effect that is direct or mediated via the local or systemic production of IGF. In human clinical studies, the administration of growth hormone has been shown to enhance the transmucosal transport of water, electrolytes, and nutrients.

Forty-one SBS patients were randomized to a double-blind, controlled, parallel-group phase 3 clinical study to evaluate the efficacy and safety of the administration of Zorbtive in subjects with SBS who were dependent on intravenous parenteral nutrition (IPN) for nutritional support. The primary end point was the change in weekly total IPN volume defined as the sum of the volumes of IPN, supplemental lipid emulsion (SLE), and intravenous hydration fluid. Patients on Zorbtive demonstrated a mean change of -3.0 to -4.2 days of IPN/SLE use compared with –2.0 days in the control group.

Zorbtive (somatropin [rDNA origin]) for Injection Labeling


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