Rx Product News

Marketed by: Forest Laboratories (New York, NY) and Almirall (Barcelona, Spain)

Indication: The FDA announced the approval of Tudorza Pressair (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. The dosage of Tudorza Pressair is 1 inhalation, which contains 400 mcg aclidinium, twice daily. It is not intended for use as a rescue medication. Patients who experience paradoxical bronchospasm while taking Tudorza Pressair should discontinue its use. Dosage Form: Inhalation powder: 400 mcg aclidinium per actuation

For More information: www.tudorzahcp.com

Advate

Marketed by: Baxter Healthcare (Westlake Village, CA)

Indication: Advate (Antihemophilic Factor [recombinant] Plasma/Albumin-Free Method) was approved by the FDA in a new dosage strength of 4000 IU. Advate is approved for use in adults and children aged 1 to 16 years with hemophilia A for the control and prophylaxis of bleeding episodes as well as for perioperative management of the disorder. This new strength will provide single-vial dosing for some adult patients with hemophilia A. Dosage Form: Single-use vials containing lyophilized powder for reconstitution for intravenous injection: 250, 500, 1000, 1500, 2000, 3000, or 4000 IU

For More information: www.advate.com

Prepopik

Marketed by: Ferring Pharmaceuticals Inc (Parsippany, NJ)

Indication: Prepopik (sodium picosulfate, magnesium oxide, and anhydrous citric acid) for oral solution is an osmotic laxative approved by the FDA for the cleansing of the colon in preparation for colonoscopy. Prepopik is supplied as a powder that must be reconstituted with cold water prior to administration. The lowest volume colon preparation available, Prepopik has 2 possible dosing regimens available to patients. Dosage Form: For oral solution: 2 packets, each containing 10 mg sodium picosulfate, 3.5 g magnesium oxide, and 12 g anhydrous citric acid

For More information: www.prepopik.com

Erbitux

Marketed by: Bristol-Myers Squibb Co (Princeton, NJ) and Eli Lilly and Co (Indianapolis, IN)

Indication: The FDA expanded the indication for Erbitux (cetuximab) for use as an initial treatment for colorectal cancer that is metastatic under the condition that patients take an FDAapproved test to predict the drug’s efficacy. Before administration, patients should be premedicated with an H1 antagonist. The initial dose of Erbitux is 400 mg/m2 in a 120-minute intravenous (IV) infusion, followed by weekly 60-minute 250 mg/m2 infusions. The product carries a boxed warning regarding the risk of serious and sometimes fatal infusion reactions and the risk of cardiopulmonary arrest and/or sudden death. Dosage Form: Single-use vial for IV infusion: 100 mg/50 mL and 200 mg/100 mL

For More information: www.erbitux.com