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FDA rejection 10 articles

European drug regulators approve new type 2 diabetes treatment

European drug regulators have approved Eli Lilly and Boehringer Ingelheim’s new Type 2 diabetes drug epagliflozin, which will be marketed under the brand name Jardiance. The once-daily tablet is designed to reduce blood sugar levels by blocking glucose reabsorption in the kidneys and remove excess glucose through the urine. Unlike other diabetes treatments, Jardiance does not rely on a patient’s insulin levels in order to be effective. Jardiance is in a class of Type 2 diabetes drugs known as sodium glucose co-transporter 2 (SGLT-2) inhibitors. Other drugs in this class include Canagliflozin, which was the first in the class to ... Read More

New diabetes drug gets positive review from European drug advisors

An advisory committee for the European drug authority is recommending the approval of empagliflozin, a new type 2 diabetes drug made by Boehringer Ingelheim and Eli Lilly and Company. Empagliflozin is in a new class of diabetes drugs known as sodium glucose co-transporter 2, or SGLT-2, inhibitors. It works by targeting glucose directly and works independently of B-cell function and insulin resistance. The drug produces increased urinary glucose excretion, with a consequent lowering of plasma, glucose levels, and weight loss. If approved, the empagliflozin would be marketed under the name Jardiance. Earlier this month, the U.S. Food and Drug Administration ... Read More

Controversy surrounds upcoming FDA decision on long-acting testosterone drug

The Food and Drug Administration (FDA) is expected to decide this week the fate of a long-acting testosterone product made by Endo Health Solutions, Inc. Aveed, indicated to boost testosterone in men with low levels of the hormone, has been rejected by the agency twice before based on health risks. Aveed, sold in other countries under the brand name Nebido, received mixed reactions from FDA advisors last year. The panel was split 9-9 on whether to recommend approval of the drug. Some advisors said the drug offers a valuable alternative to existing shorter-acting products, such as AndroGel, Testim and Axiron. ... Read More

FDA rejects another drug aimed at increasing female libido

The decades-long search for a female equivalent to the libido-boosting drug Viagra for men will not be filled any time soon. The latest drug candidate, Sprout Pharmaceuticals’ filbanserin, was rejected by the Food and Drug Administration (FDA). The agency questioned whether the drug’s benefits – which it said were “modest” at best – outweighed the potential side effects, which include fatigue, dizziness and nausea. Developing drugs to boost female sexual desire is a complicated science because the root cause can be multifaceted – such as psychological – and thus harder to understand and measure. “And, quite honestly, we don’t know enough about ... Read More

Drug company Orexigen conducts tests on experimental diet pill Contrave

Interim analysis of Orexigen Therapeutics’ experimental weight loss drug Contrave showed successful results, setting the stage for possible marketing approval by United States drug regulators by June 2014. The Food and Drug Administration (FDA) rejected Orexigen’s bid for approval in February 2011, saying it needed more data from a large-scale study on the long-term effects the obesity medication has on the heart. Contrave is a combination of two already approved medications – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in in order to decrease food ... Read More

FDA panel rejects non-hormonal menopause treatment

An experimental non-hormonal treatment for menopause was rejected by a Food and Drug Administration advisory panel this week because the group found risks associated with the drug were greater than any benefit it offered. Drug maker Depomed submitted for approval Seflsa, known generically as gabapentin, a medication that has long been used to treat pain and seizures. It is also prescribed off-label by doctors to treat menopause symptoms. Depomed asked the FDA to approve this use, which would allow the company to market it as a menopause treatment. The panel’s decision to vote against approving Seflsa is based on studies that ... Read More

Newly approved type 2 diabetes drugs come with warnings, requirements

After more than five years of reviews and rejections, the dipeptidyl peptidase IV (DDP-4) inhibitor alogliptin has finally been approved by the Food and Drug Administration (FDA). The new drug was approved in three versions to improve blood sugar control in adults with type 2 diabetes. Nesina contains alogliptin as a single-agent drug; Kazano contains alogliptin with metformin; and Oseni contains alogliptin with pioglitazone. The drugs are to be prescribed in combination with diet and exercise. Alogliptin is the fourth DDP-4 inhibitor to gain FDA clearance. Others include sitagliptin, sold under the brand name Januvia; saxagliptin, sold as Onglyza; and ... Read More

FDA approves first-ever migraine medicine skin patch

NuPathe is launching the first-ever patch to treat migraine headache, a product the device’s maker says is “game changing” to migraine sufferers. The Food and Drug Administration (FDA) gave NuPathe’s Zecuity the nod last week, and the company says it is currently focusing on securing commercial partners for the patch and hopes to have the patch on the market by the end of the year. Zecuity is a single-use, battery-powered patch that actively delivers the migraine medication sumatriptan through the skin. Sumatriptan has been on the market since 1991. It is administered in several forms including tablets, subcutaneous injection, and ... Read More

Merck seeks approval for previously rejected combination cholesterol drug

Merck & Co. is resubmitting the drug application for its combination cholesterol-lower drug MK-0653C, which was rejected by the Food and Drug Administration (FDA) last March due to insufficient data. The experimental medication combines a generic version of the cholesterol-lowering drug Lipitor, the top-selling medication of all time, with Merck’s cholesterol med Zetia. Lipitor and Zetia work in different ways to reduce high cholesterol and thus reduce the risk of heart attack and stroke. Lipitor, also known as atorvastatin, is a member of the statin drug family, which reduce the amount of cholesterol naturally produced in the liver. Zetia reduces the ... Read More

Drug company wants to speed review process for new diet drug Contrave

Orexigen Therapeutics Inc. is hoping the Food and Drug Administration (FDA) will grant its request to speed up the review process for its obesity drug Contrave. The agency rejected the weight loss drug in February 2011, saying it needed data from a large-scale study on the long-term cardiovascular effects associated with the medication before approval would be granted. Contrave is a combination of two medications already approved by the FDA – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in order to decrease food intake over ... Read More