Skip to Content

Weekly Drug News Round Up - January 28, 2015

Teva’s Generic Esomeprazole is FDA-Approved for Nexium

Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach Read More...

If you have acid reflux, otherwise known as gastroesophageal reflux disease (GERD) or heartburn, you probably know the medication Nexium (esomeprazole). Now, the first generic version of the blockbuster heartburn drug has been approved by the U.S. Food and Drug Administration. What does this mean for you? Prices will come down, although when and by how much is not known yet. Esomeprazole will be available in 20- and 40-milligram capsules. Esomeprazole also is approved to reduce the likelihood of NSAID-induced stomach ulcers and to treat H. pylori stomach infection linked to ulcers. Bone fractures and severe diarrhea are serious side effects.

FDA Approves Triferic for Iron Replacement in Hemodialysis

Triferic is the only iron replacement therapy that can be delivered via the dialysate solution Read More...

The U.S. Food & Drug Administration (FDA) has approved Rockwell Medical’s Triferic (ferric pyrophosphate citrate) as an iron replacement product to maintain hemoglobin in adults with hemodialysis dependent chronic kidney disease (CKD). Triferic is a unique iron compound that is delivered to hemodialysis patients via dialysate. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. In completed clinical trials to date, Triferic has demonstrated that it can effectively deliver sufficient iron to the bone marrow to maintain hemoglobin and not increase iron stores (ferritin).

Natpara Wins Approval for Hypocalcemia in Patients with Hypoparathyroidism

Natpara carries a boxed warning that bone cancer (osteosarcoma) has been observed in rat studies Read More...

The U.S. Food and Drug Administration today approved Natpara (parathyroid hormone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States. Patients with hypoparathyroidism can experience numbness, tingling, muscle twitching, cramps, abnormal heart rhythm, and seizures as a consequence of low blood calcium levels. Hypoparathyroidism occurs most commonly as a result of surgical removal of the parathyroid glands, which help regulate calcium and phosphorus levels in the body. Natpara is an injection given once a day.

New Bacterial Meningitis Vaccine Bexsero Approved

In meningococcal disease bacteria can invade the bloodstream (sepsis), the brain and spinal cord lining (meningitis) Read More…

Recent outbreaks of potentially deadly group B meningitis on U.S. college campuses have led to concern from parents and students. Bexsero is a new vaccine by Novartis to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Bexsero was FDA-approved this past week as the second vaccine to help prevent Group B meningitis. In Bexsero studies, after two vaccine doses, 62 to 88 percent of participants had antibodies that killed three different N. meningitidis serogroup B strains. Previously, other vaccines approved for meningococcal disease only covered four of the five main serogroups of N. meningitidis: A, C, Y, and W, but not group B.

FDA Consumer Update: Targeting Pancreatic Cancer

The five-year survival rate for a pancreatic cancer diagnosis is only 5 percent Read More...

Pancreatic cancer is one of the most worrisome of all cancers due to its low survival rate and rapid progression. However, advances in drug treatment are under research to offer hope to the 46,000 plus people that are diagnosed with pancreatic cancer each year. Researchers are investigating targeted therapies that aim for the KRAS mutation found in pancreatic tumors, as well as immune therapies - a technique that has shown success in melanoma treatment. FDA has approved three treatments in the past 20 years for advanced pancreatic cancer to help patients live longer: Gemzar (gemcitabine), Tarceva (erlotinib) in combination with gemcitabine, and, nab-paclitaxel in combination with gemcitabine.

Hide