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FDA approves treatment for fat below the chin

May 21, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended. [Read more…]

Filed Under: FDA News & Alerts Tagged With: obesity

FDA issues proposed rule to address data gaps for certain active ingredients in health care antiseptics

May 21, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Antiseptics, Hand Sanitizer

FDA approves Raplixa to help control bleeding during surgery

May 21, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Raplixa

FDA approves additional antibacterial treatment for plague

May 21, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. The agency approval for plague includes use of the drug for the treatment of pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood). Avelox is also approved for prevention of plague in adult patients. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Avelox (moxifloxacin), Bayer Pharmaceuticals, Plaugue

FDA approves spinal cord stimulation system that treats pain without tingling sensation

May 21, 2015 By MedNews Leave a Comment

Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulation amplitudes. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Nevro Corp., Pain Management, Senza System

FDA releases draft guidance on animal drug compounding from bulk drug substances

May 21, 2015 By MedNews Leave a Comment

As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.” Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes that there are limited circumstances when an animal drug compounded from bulk drug substances may be an appropriate treatment option.   [Read more…]

Filed Under: FDA News & Alerts Tagged With: Drug Compounding, Drug Quality and Security Act

FDA proposes rule to collect antimicrobial sales and distribution data by animal species

May 21, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration proposed a rule today that would require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species (cattle, swine, chickens and turkeys). The additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.
[Read more…]

Filed Under: FDA News & Alerts Tagged With: antimicrobial

FDA Approves Simponi to Treat Ulcerative Colitis

May 15, 2013 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.

Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Andrew E. Mulberg, colitis, fda, golimumab, Janssen Biotech, Simponi

New Tool to Help Prevent Intentional Food Contamination

April 25, 2013 By MedNews Leave a Comment

The U.S. Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities.

The FDA does not require food facilities to implement food defense plans, but many facilities have voluntarily put such plans into place to safeguard their products. [Read more…]

Filed Under: FDA News & Alerts Tagged With: fda, food contamination

Cialis Approved to Treat Benign Prostatic Hyperplasia

October 6, 2011 By MedNews Leave a Comment

Cialis (tadalafil) was approved today by the FDA for treating the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.

Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urination including at night.

The severity of symptoms of BPH can be measured using the International Prostate Symptom Score (IPSS). In two clinical trials, men with BPH who took 5 milligrams (mg) of Cialis once daily experienced a statistically significant improvement in their symptoms of BPH compared to men who were treated with placebo. The trials based their findings on a reduction in total IPSS scores.

In a third study, men who experienced both ED and BPH and who took 5 mg of Cialis once daily had improvement in both their symptoms of BPH and in their ED compared to men who were treated with placebo. The improvement in ED was measured using the Erectile Function domain score of the International Index of Erectile Function.

“BPH can have a big impact on a patient’s quality of life,” said Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men.”

Cialis should not be used in patients taking nitrates, for example nitroglycerin, because the combination can cause an unsafe decrease in blood pressure. Also, the use of Cialis in combination with alpha blockers for the treatment of BPH is not recommended because the combination has not been adequately studied for the treatment of BPH, and there is a risk of lowering blood pressure.

The FDA has approved eight other drugs to treat symptoms of BPH: Proscar, (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha blockers: Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

Cialis is manufactured by Indianapolis-based Eli Lilly and Co.

Source: FDA

Filed Under: FDA News & Alerts Tagged With: alfuzosin, Avodart, Benign Prostatic Hyperplasia, BPH, Cardura, Cialis, doxazosin, dutasteride, Eli Lilly, finasteride, Flomax, Hytrin, International Prostate Symptom Score, Jalyn, Proscar, Prostate, Rapaflo, Scott Monroe, silodosin, tadalafil, tamsulosin, terazosin, Uroxatral

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