FDA approves Bayer’s Xofigo for treatment of prostate cancer
May 16th 2013FDA has approved radium Ra 223 dichloride (Xofigo, Bayer) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.
FDA approves Breo Ellipta for long-term treatment of COPD
May 13th 2013FDA has approved fluticasone furoate and vilanterol inhalation powder (Breo Ellipta, GlaxoSmithKline and Theravance), an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
FDA approves combination agent to help lower LDL cholesterol
May 6th 2013FDA has approved ezetimibe and atorvastatin (Liptruzet, Merck) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet, according to the manufacturer.
New biologic Xeljanz Tofacitinib Pfizer
May 1st 2013In November 2012, FDA approved tofacitinib (Xeljanz, Pfizer) 5 mg tablets for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have not had an adequate response to methotrexate or are intolerant to methotrexate. Tofacitinib, an oral non-biologic disease-modifying antirheumatic drug (DMARD) can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. It is contraindicated for use with biologic DMARDs or with immunosuppressive agents, such as azathioprine and cyclosporine.
FDA approves combination glaucoma drop without beta-blocker
April 23rd 2013FDA approved a new fixed-dose combination ophthalmic suspension of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%), which is indicated for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
FDA approves first oral agent for OIC in adults with chronic noncancer pain
April 23rd 2013FDA has approved a supplemental new drug application (sNDA) for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda Pharmaceuticals) 24 ?g twice daily as the first oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, noncancer pain.
FDA nixes generic OxyContin, approves abuse-deterrent labeling for reformulated OxyContin
April 17th 2013FDA announced April 16 that it will not approve any generic versions of the original OxyContin formulation as the benefits no longer outweigh its risks. The original OxyContin was withdrawn from sale for reasons of safety, as it could be easily misused and abused by crushing and snorting. The original formulation was approved in 1995.
FDA approves Diclegis for treatment of pregnancy morning sickness
April 9th 2013FDA has approved doxylamine succinate 10 mg, pyridoxine hydrochloride 10 mg (Diclegis, Duchesnay) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management, including dietary and lifestyle modifications. These modifications include eating several small meals instead of 3 large meals, eating bland foods that are low in fat and easy to digest, and avoiding smells that can trigger nausea.
Diabetes drug canagliflozin receives FDA approval
April 1st 2013Diabetes drug canagliflozin (Invokana, Janssen Pharmaceuticals) is the first drug approved by the FDA in a new class known as sodium-glucose co-transporter 2 (SGLT2) inhibitors to be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, according to Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research.
Biogen receives FDA approval for new MS treatment
March 27th 2013FDA approved dimethyl fumarate (Tecfidera, Biogen Idec) capsules for the treatment of adults with relapsing forms of multiple sclerosis (MS), including the most common form, relapsing-remitting multiple sclerosis (RRMS), according to an FDA statement on March 27.
FDA approves Lymphoseek Injection for use in lymphatic mapping
March 13th 2013FDA approved (technetium Tc 99m tilmanocept (Lymphoseek, Navidea Biopharmaceuticals) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.
FDA approves first generic Suboxone for maintenance treatment of opioid drug dependence
February 25th 2013FDA has approved generic buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets (Amneal Pharmaceuticals), the first generic generic versions of Suboxone (Reckitt Benckiser Healthcare (UK)) sublingual tablets for maintenance treatment of opioid drug dependence.
FDA approves new multiple myeloma drug with REMS
February 11th 2013FDA has approved pomalidomide (Pomalyst, Celgene) to treat patients who have received at least 2 prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Antipsychotic drugs improve life expectancy for schizophrenia patients
November 29th 2012Individuals with schizophrenia are significantly more likely to live longer if they take their antipsychotic drugs on schedule, avoid extremely high doses, and also regularly see a mental health professional, according to results of a Johns Hopkins study, published in Schizophrenia Bulletin.