Novartis announced that the FDA has approved Tekturna (aliskiren) tablets, the first in a new class of drugs called direct renin inhibitors. A once-daily oral therapy, Tekturna acts by targeting renin -- an enzyme responsible for triggering a process that can contribute to high blood pressure. This condition is a leading contributor to cardiovascular disease, considered the world's leading cause of death. Tekturna received FDA approval for treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications. The use of Tekturna with maximal doses of ACE inhibitors has not been adequately studied. Tekturna is expected to be available later this month in pharmacies as 150 mg and 300 mg tablets.
Salix Pharmaceuticals has purchased the US prescription pharmaceutical product rights to Pepcid oral suspension and Diuril oral suspension from Merck. Pepcid oral suspension is indicated for several gastrointestinal indications including the treatment of duodenal ulcer, benign gastric ulcer and gastroesophageal reflux disease. Under the terms of the agreement, Salix will make a $55 million up-front payment and up to $6 million in potential sales-based milestone payments to Merck.
The FDA has approved Alpharma’s Kadian (morphine sulfate extended-release) 200 mg capsule for the management of moderate-to-severe chronic pain, when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The company expects to launch this new dosage strength in the second quarter of 2007. Kadian is Alpharma's branded extended release morphine sulfate product and is currently marketed in 20 mg, 30 mg, 50 mg, 60 mg, 80 mg and 100 mg dosages. The added dosage strength is intended to assist in physicians' efforts to individualize their patient's treatments by offering more choices in managing their pain.
The FDA has approved Pfizer’s Cerenia (maropitant citrate), the first drug to prevent and treat vomiting in dogs. When used in tablet form, the drug can prevent vomiting associated with motion sickness, the FDA said. The agency also approved an injectable form of the drug that it said can prevent and treat acute vomiting due to chemotherapy, parvovirus, kidney disease, pancreatitis and other causes. Severe vomiting can lead to dehydration and death in dogs, the FDA said.
The FDA has approved King Pharmaceuticals’ new drug application for an Altace (ramipril) tablet formulation. King expects to be in a position to launch the new formulation sometime during the fourth quarter of 2007 or the first quarter of 2008.
Teva Pharmaceutical Industries said the FDA granted approval for its 0.5 mg, 1 mg, 2 mg and 3 mg alprazolam extended release tablets, for treatment of panic disorder. The drug is a generic version of Pharmacia and Upjohn's Xanax XR tablets.
Astellas Pharma US, announced that the FDA has approved Vaprisol (conivaptan hydrochloride injection), an arginine vasopressin (AVP) receptor antagonist, for the intravenous treatment of hypervolemic hyponatremia in hospitalized patients. Vaprisol, discovered and developed by Astellas, is the first drug specifically indicated for the treatment of both euvolemic and hypervolemic hyponatremia, potentially life-threatening conditions that occur when the body's blood sodium level falls significantly below normal. Vaprisol was approved by the FDA as a treatment for euvolemic hyponatremia in December 2005, and has been marketed by Astellas since April 2006.
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