Drug Pipeline

Amgen has submitted a supplemental Biologics License Application to FDA to expand the indication for Xgeva to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases, according to a company press release.

FDA granted approval to Pfizer and Acura Pharmaceuticals for a new formulation of oxycodone hydrochloride (HCl) (Oxecta USP Tablets CII) that is designed to be tamper resistant, according to a joint statement from the 2 companies.

FDA approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people aged 18 and older.

In an effort to address the efficacy of various treatment options available to reduce pain and improve physical function and quality of life (QOL) in patients with painful diabetic neuropathy (PDN), a broad literature review was conducted and new guidelines were published online May 17 in Neurology, as well as presented at the American Academy of Neurology Annual Meeting in Honolulu.

FDA has announced more conservative dosing recommendations for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.

The 5-alpha-reductase inhibitor dutasteride is associated with markedly lower BPH-related complication rates than the alpha-blocker tamsulosin, according to analysis of 2 large trials.

Individualized guidelines present a much more efficient way of using drugs and other treatments compared with current guidelines.

The incidence of Alzheimer's disease is expected to increase through the year 2050 with an estimated prevalence of 11 to 16 million cases. Two classes of medications are FDA approved for managing symptoms of AD, cholinesterase inhibitors and an N-methyl-D-aspartase receptor antagonist..

Generic drug approved by FDA (through June 2011): levofloxacin

Recent FDA Approvals (through June 2011) related to Oxecta, Creon, Lupron Depot, Nulojix, Zutripro Oral Solution, Potiga, Solesta, Dificid, Istodax, Rectiv, IaViv

FDA is developing guidelines for documenting similarity and interchangeability of copycat versions of biotech therapies, a process that is drawing considerable scrutiny from a broad spectrum of stakeholders.

With more and more costly drugs breaking the bank for patients and payers, managed care organizations are developing programs to reduce a small niche of waste associated with early discontinuation of medication therapy.

Comparative effectiveness research reviews are valuable resources for guiding medication use decisions, but they are underutilized, according to a recent presentation.

In a recently published study, researchers have presented new evidence suggesting that oral contraceptives containing drospirenone result in a greater than 2-fold increased odds of developing non-fatal, idiopathic venous thromboembolism compared to current users of products containing levonorgestrel.

The selective beta3-adrenoceptor agonist mirabegron effectively improves symptoms of overactive bladder and is very safe and well tolderated, according to results of a phase 3 study.

New studies confirm the lower levels of vitamin D are associated with a higher risk of developing diabetes and diabetic retinopathy.

New indication: Menactra Quadrivalent meningococcal polysacchardie diptheria toxoid conjugate vaccine was approved by FDA as treatment to prevent meningococcal disease in infants and toddlers as young as 9 months of age.

According to a new safety communication recently released by FDA, the agency is continuing to receive reports of a rare but aggressive white blood cell cancer often referred to as hepatosplenic T-cell lymphoma in patients receiving tumor necrosis factor blockers, azathioprine, and mercaptopurine.

New molecular entity: Vandetanib is a oral kinase inhibitor approved by FDA to treat progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Some of the most prescribed blockbuster medications will lose market exclusivity in the next couple of years, according to a recent presentation.

Rivaroxaban is an oral, direct factor Xa inhibitor under review by FDA for stroke prevention in patients with atrial fibrillation. Atrial fibrillation conveys a 5-fold increased risk for stroke.

Recent FDA action (through June 2011) related to oxycodone, aflibercept opthalmic solution, icatibant, eculizumab, asimadoline, anthrax vaccine, SBC-102 enzyme replacement therapy, ciprofloxacin, mitosol, MORAb-004 and MORAb-066, levofloxacin.

In a recently published observational registry study, researchers have demonstrated that the utilizatio of evidence-based therapies in patients experiencing ST-elevation myocardial infarction is on the rise.

Low-cost generic drug programs pioneered by Wal-Mart and other big-box retailers are a mixed blessing for patients with diabetes.

Crizotinib demonstrated an association with a sharp increase in survival rates for patients with advanced non-small cell lung cancer with an anaplastic lymphoma kinase positive genetic alteration, according to the results of a study presented at the annual meeting of the American Society of Clinical Oncology.

Safety information regarding varenicline will be added to the Warnings and Precautions section of the label and to the patient Medication Guide because smoking cessation aid varenicline may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.

Study shows that several common antiepileptic drugs pose the risk of major congenital malformations and that risk increases dose-dependently.

FDA announced changes to safety labels for simvastatin, Vytorin, and Simcor, including dosing recommendations and is advising physicians to limit the use of 80-mg simvastatin due to an increased risk of myopathy.

The Center for Drug Evaluation and Research recently announced that it will elevate the Office of Compliance to a Super Office to continue to ensure the safety, quality, and integrity of drugs in America, according to a memo from CDER Director Janet Woodcock.

Budesonide/Formoterol maintenance and reliever therapy is an effective option for patients requiring treatment adjustments across Steps 2 to 4 of the Global Initiative for Asthma guidelines, according to the results of a study published online, June 2 in Respiratory Research.