The US Food and Drug Administration (FDA) has approved Vardenafil (generic name: Sildenafil) tablets for erectile dysfunction (ED) as “generic”. The drug, which is sold under the brand name Levitra, is marketed by Pfizer Inc.
FDA officials said they are reviewing the agency’s approval process to determine whether the tablets are medically appropriate for the condition.
The drug was developed to treat the symptoms of Erectile Dysfunction (ED) in men.
“The FDA has reviewed the safety and efficacy of Vardenafil and determined that it is a safe and effective treatment for ED,” said Janet Woodcock, the FDA’s director of research and marketing.
In June, the agency approved a Phase 3 trial to evaluate whether the medicine could increase the rate of progression of ED in patients with cardiovascular disease.
The trial involved 682 patients with mild-to-moderate ED who were randomized to receive either a daily 10 mg dose of Vardenafil or placebo for three months.
When compared with the 10 mg dose, the study patients improved significantly faster, with an average increase of 4.5 days in ED-related quality of life (ADQOL) and 2.4 days in the placebo group, Woodcock said.
The trial randomized patients to receive a daily 10 mg dose of Vardenafil or placebo for three months. The study also examined the effect of Vardenafil on blood pressure, heart rate and blood pressure before and after the drug was started and during the treatment period.
The average time the trial took to reach a conclusion on the efficacy of the drug was 10.6 days, Woodcock said.
“The FDA has concluded that there is no evidence that Vardenafil improves erectile function in men with mild-to-moderate ED,” she said.
The FDA has also not approved the use of Vardenafil to treat pulmonary arterial hypertension, another condition that is linked to high blood pressure in the lungs, Woodcock added.
Originally Published: July 7, 2008 at 12:00 AM EDT
Read Next on FDA approvals of Levitra for erectile dysfunction:Learn more about Levitra's approval, benefits, and side effectsLast year, the FDA approved the first and only drug to treat erectile dysfunction in men. FDA spokeswoman Mary Lou Marzian said the drug has the potential to “grow into the hands of physicians and patients.”
Drugmakers have been trying to develop new drugs to treat ED since the late 1990sBut now, as the FDA approves new drugs to treat erectile dysfunction, they are also trying to develop new treatments to treat pulmonary arterial hypertension and other conditions that have been linked to high blood pressure in the lungs. The FDA also is reviewing the use of medications to treat the condition.
In the meantime, the FDA has issued a public relations blitz to promote the drugs, including ads for the Viagra brand, for men with erectile dysfunction.
“FDA has been working with the Food and Drug Administration to review all of the available information about the efficacy of Vardenafil as a treatment for ED, and has requested approval from the FDA for Levitra,” said FDA spokesman Daniel Merkley. “We are reviewing the data, including results from Phase 3 trials, and are reviewing the safety and efficacy data from the safety and efficacy studies.”
FDA officials said they are still reviewing the agency’s approval process, but are reviewing the results of the drug’s safety and efficacy studies.
The FDA’s approval of Vardenafil came just a few years after the first and only FDA approval of Viagra, the erectile dysfunction drug for men.
In 2010, it was approved for sale by the FDA.
Viagra is the brand name of sildenafil, a drug used to treat erectile dysfunction in men. It is manufactured by Pfizer Inc. It’s available in four dosages: 25 mg, 50 mg, 100 mg, 150 mg and 200 mg.
The FDA has granted approval for the treatment of erectile dysfunction in men. The drug has been approved for the treatment of pulmonary arterial hypertension.
Overview:Levitra is a medication that is used to treat erectile dysfunction (ED). It is used to treat ED when you are experiencing a sudden inability to get or keep an erection firm enough for sex. Levitra works by increasing blood flow to the penis, which helps to achieve and maintain an erection.
Key Features:
Important Information:
Disclaimer:
This article is for informational purposes only and does not constitute medical advice. Always consult a healthcare professional before starting any new medication.
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Levitra is a medication used to treat erectile dysfunction (ED) in men. It belongs to a group of drugs called phosphodiesterase type 5 (PDE5) inhibitors. Levitra works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited.
Levitra is available in tablets, oral jelly and as a liquid medication. The recommended starting dose is 10 mg, taken as needed approximately one hour before sexual activity. Levitra should not be taken more than once in a 24-hour period.
Levitra works by increasing the amount of nitric oxide produced in the body, which relaxes the blood vessels in the penis. This helps to improve blood flow and the ability to get and maintain an erection. Levitra is also used to treat pulmonary arterial hypertension.
It can be taken as a daily or as a once-a-day pill. The recommended dosage is 10 mg. You should take the medication at least 30 minutes before sexual activity.
Levitra is also available as a liquid medication and as a chewable tablet. Levitra is available in different dosages. You should take the medication at least 60 minutes before sexual activity.
Before taking Levitra,
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