Pernix Therapeutics (Magnolia, TX)
Omeclamox-Pak (omeprazole delayed-release capsules USP, 20 mg; clarithromycin tablets USP, 500 mg; amoxicillin capsules USP, 500 mg) is indicated for the treatment of Helicobacter pylori
infection and duodenal ulcer disease (either an active or a 1-year history of duodenal ulcer disease) to eradicate H pylori
. Omeclamox-Pak is a 10-day, triple combination oral therapy. Each administration card contains a proton pump inhibitor, a macrolide antimicrobial, and a penicillin class antibacterial. The medication should be given in the morning and evening before eating a meal.
Capsules: 20 mg omeprazole, 500 mg clarithromycin; tablets: 500 mg amoxicillin
For More Information: www.omeclamox.com
: NPS Pharmaceuticals (Bedminster, NJ)
NPS Pharmaceuticals announced the approval of Gattex (teduglutide [rDNA origin]) for subcutaneous administration, a once-daily injection that helps improve intestinal absorption of fluids and nutrients for adult patients with short bowel syndrome who are dependent on parenteral support. The drug was approved with a Risk Evaluation and Mitigation Strategy because of the increased risk of developing cancer, abnormal polyps, or obstructions in the intestine; gallbladder disease; biliary tract disease; and pancreatic disease.
Subcutaneous injection: single-dose, pre-filled syringe with 5 mg of teduglutide as a white, lyophilized powder for reconstitution with 0.5 mL sterile water in a pre-filled syringe
For More Information: www.gattex.com
Aegerion Pharmaceuticals Inc (Cambridge, MA)
The FDA approved orphan drug Juxtapid (lomitapide) for patients with homozygous familial hypercholesterolemia, a rare genetic condition that prevents the body from effectively removing cholesterol from the blood. Intended for use in combination with a low-fat diet, Juxtapid works to reduce the levels of low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein cholesterol circulating in the blood. Juxtapid carries a boxed warning against the risk of hepatic toxicity.
Capsules: 5, 10, and 20 mg
For More information: www.juxtapid.com
Edgemont Pharmaceuticals (Austin, TX)
Edgemont Pharmaceuticals announced that the FDA approved Forfivo XL (bupropion hydrochloride extended-release tablets), a higher dose version of their bupropion product that was originally approved in 1985. Forfivo XL is an aminoketone indicated for the treatment of major depressive disorder. Patients should not initiate treatment with Forfivo XL; the medication is specifically for patients who used another bupropion product for initial titration and require dosages of 450 mg/ day. The drug carries a boxed warning for the increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder.
: Tablets: 450 mg
For More Information: www.forfivoxl.com