Amlodipine Mesylate

In its announcement on Thursday, the FDA said its preliminary tests of alternative antacid treatments such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) currently show no NDMA at this time based on testing. Amy Lutz / Shutterstock While the U.S. Food and Drug Administration (FDA) continues to test ranitidine-based products for potential contamination of the known carcinogen N-nitrosodimethylamine (NDMA), the regulatory agency released a list of alternative products that have been found free of the contaminant. In its announcement on Thursday, the FDA said its preliminary tests of alternative antacid treatments such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) currently show no NDMA at this time based on testing. The testing was conducted after the carcinogen was found in Sanofi’s Zantac, which prompted the company to issue a voluntary recall of its product from pharmacies in the U.S. and Canada Multiple pharmacy retailers , including CVS, Walgreens and Rite Aid have already removed ranitidine from their shelves until FDA reviews are complete. On Thursday, the regulatory agency announced it was issuing an additional testing method to the manufacturers of ranitidine to test for NDMA. In addition to Sanofi, Dr. Reddy’s Laboratories also issued a voluntary recall of its prescription and over-the-counter (OTC) ranitidine tablets and capsules. GlaxoSmithKline and Novartis have also recalled or stopped production of their ranitidine tablets, Reuters reported. As Reuters noted in its report, the question of whether or not Zantac had been contaminated with the carcinogen was raised by an online pharmacy, Valisure. In September, the FDA issued a report that showed some ranitidine medicines, including the brand-name drug Zantac, contain low levels of the nitrosamine impurity . NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. In large amounted NDMA can cause health problems, but the FDA said the levels it initially found in ranitidine were low, however, those levels have been considered unacceptable for the product, which at one time was the best-selling medication in the world. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. It is sold over-the-counter, with one of the most popular versions being Zantac. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease, the FDA noted in its announcement. Jeremy Kahn, a spokesman for the FDA, told Reuters that the agency is conducting the tests in order to “understand what happens to NDMA levels in the body, after ranitidine has been exposed to acid in the stomach.” David Light, the chief executive officer of Valisure said the FDA testing of ranitidine products is important because his company’s data suggests the NDMA levels that can be formed in the body “are many magnitudes of order higher than what’s been talked about in the contamination,” Reuters said. “This is one of the main red flags we’ve raised the whole time -- not just contamination but the fact that this is happening in the human body,” Light said, according to Reuters . In addition to NDMA contamination of ranitidine products, the FDA has also had to raise red flags over some blood pressure medications that have been found to have NDMA. Teva Pharmaceuticals has had to recall lots of bulk Losartan Potassium due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid discovered in the manufacturing process. That was the second recall for Israel-based Teva. November 2018, the company issued a voluntary recall for combination forms of its blood pressure drug Amlodipine due to cancer-causing impurities. In March, the FDA raised concerns about losartan potassium tablets sold by India-based Hetero Labs Ltd. and distributed by Camber Pharmaceuticals. Also last fall, the FDA issued a voluntary recall for lots of Irbesartan tablets developed by N.Y.-based ScieGen Pharmaceuticals due to the presence of the carcinogen. hbspt.forms.create({ portalId: "4413123", formId: "c4dda430-e2b0-4083-86f3-ccce0c1d4479" });

The FDA approval marks the first drug approved for Azurity, a company formed from the merger of CutistPharma and Silvergate. Privately-held Azurity Pharmaceuticals won approval for a liquid form of a hypertension drug for both adult and pediatric patients. This morning, Woburn, Mass.-based Azurity said the U.S. Food and Drug Administration (FDA) approved Katerzia (amlodipine) Oral Suspension. This is the only FDA-approved amlodipine oral suspension, the company said. Katerzia is indicated for the treatment of hypertension (high blood pressure) in adults and pediatric patients six years of age and older and coronary artery disease in adults. Amlodipine is a calcium channel blocker that dilates blood vessels and improves blood flow in patients with hypertension, as well as other conditions caused by coronary artery disease. Hypertension is a common ailment, occurring in about 75 million American adults. Hypertension, which often goes uncontrolled, increases the risk for heart disease and stroke, which are two of the leading causes of death for adults in the United States. Hypertension in children and adolescents is a growing concern. According to the U.S. Centers for Disease Control and Prevention, about 4% of youth aged 12–19 years have hypertension, and another 10% have elevated blood pressure, previously called pre-hypertension. Azurity is a newly branded specialty pharma company formed last month following CutisPharma’s acquisition of Silvergate Pharmaceuticals, Inc. The unified company rebranded itself as Azurity Pharmaceuticals. Azurity focuses on the needs of patients, particularly children and the elderly, who require customized, user-friendly drug formulations. The approval of Katerzia is the first product approval since the formation of the unified companies. The company did not provide details on list pricing or when the medication will be available to patients. Neal Muni, president and chief executive officer of Azurity, called it an exciting time for the merged companies. Muni said the addition of Katerzia complements the company’s existing pediatric hypertension portfolio and “will strengthen the overall offering from Azurity.” In addition to Katerzia, Azurity has several FDA-approved products in its portfolio. Epaned is an oral solution of Enalapril, another hypertension treatment for adults and pediatric patients. Qbrelis is an oral solution of Lisinopril, a hypertension treatment for pediatric patients. Xatmep is an oral solution for pediatric patients with acute lymphoblastic leukemia. Firvanq is an oral treatment for adults and pediatric patients who have Clostridium difficile -associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. Firvanq was approved by the FDA last year. At the time of its approval, it was the only FDA-approved vancomycin oral liquid treatment option for those indications.