Once-daily Exalgo™ (hydromorphone HCl) extended-release tablets have been approved by the U.S. Food and Drug Administration for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The tablets are expected to be available in the first half of 2010.
Exalgo uses the OROS® Push-Pull osmotic delivery system designed to release the opioid at a controlled rate. By providing a steady release of hydromorphone throughout the day, the drug is formulated to help minimize the peaks and troughs that are sometimes experienced by chronic pain patients who rely on products that are dosed at more frequent intervals.
Source.“FDA Approves Exalgo (Hydromorphone HCl) Extended-Release Tablets.” (2010, March 2). Retrieved March 9, 2010, from http://www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html.
Labetalol hydrochloride (HCl) injection, USP, commonly used to control severe hypertension, has received approval from the U.S. Food and Drug Administration. The product will be available in two vial sizes—100 mg per 20 mL and 200 mg per 40 mL, multi-dosage vials.
Labetalol HCl injection is the generic equivalent of Prometheus Laboratories’ Trandate® (labetalol HCl) Injection. Labetalol HCl Injection is an adrenergic receptor blocking agent that has both selective alpha-1 adrenergic and nonselective beta-adrenergic receptor blocking actions that are used to control blood pressure in severe hypertension.
Source.“Sagent Pharmaceuticals Announces FDA Approval of Labetalol Hydrochloride Injection, USP.” (2010, February 8). Retrieved March 9, 2010, from http://www.medicalnewstoday.com/articles/178538.php.
The U.S. Food and Drug Administration (FDA) has approved Crestor® (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men 50 and older and women 60 and older), high-sensitivity C-reactive protein ≥2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low high-density lipoprotein cholesterol levels, smoking, or a family history of premature coronary heart disease.
The FDA approval was based on data from the landmark JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) study, which evaluated the impact of Crestor 20 mg on reducing major CVD events in a previously unstudied population. In JUPITER, Crestor significantly reduced the relative risk of heart attack by 54% (p < 0.001), stroke by 48% (p = 0.002), and arterial revascularization by 46% (p < 0.001) versus placebo.
Source.“US FDA Approves New Indication for Crestor®(Rosuvastatin Calcium).” (2010, February 8). Retrieved March 9, 2010, from http://multivu.prnewswire.com/mnr/astrazeneca/42210/.
Results from a Phase III trial of the investigational drug dimebon in patients with Alzheimer’s disease found that dimebon did not meet its co-primary or secondary efficacy endpoints compared with placebo. Co-primary endpoints were measures of cognition (as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale) and global function (as measured by the Clinician’s Interview-Based Impression of Change Plus Caregiver Input).
Dimebon was well tolerated in both the CONNECTION study and in a separate Phase III safety and tolerability study, which confirmed dimebon’s tolerability when dosed alone or in combination with approved Alzheimer’s disease medicines.
Dimebon, an investigational oral medication being tested as a potential treatment for Alzheimer’s disease and Huntington disease, is being studied in four other ongoing randomized, double-blind, placebo-controlled Phase III studies, which currently are enrolling.
Source.“Pfizer and Medivation Announce Results from Two Phase 3 Studies in Dimebon (Latrepirdine) Alzheimer’s Disease Clinical Development Program.” (2010, March 3). Retrieved March 9, 2010, from http://www.drugs.com/clinical_trials/pfizer-medivation-announce-results-two-phase-3-studies-dimebon-latrepirdine-alzheimer-s-clinical-8928.html.…