The FDA has approved several drugs to treat high blood pressure, and the new drug approval is a major step in the fight against counterfeit drugs.
The Food and Drug Administration (FDA) is encouraging manufacturers of high-quality versions of Pfizer's drugs to market the pills, which are made of identical ingredients.
The drugmakers will take the steps necessary to obtain FDA approval before the generic versions of the drugs are approved for sale.
The approval is part of efforts to create a market for drugs that are more likely to be counterfeit than good.
The FDA says it will also consider the safety and effectiveness of the drug. The approval could lead to increased competition for the drug and its formulations, which have been widely used in medical journals for years.
“I don’t think this is a magic bullet,” said Michael E. Rosen of the Cleveland Clinic, a clinical toxicology specialist at Cleveland Clinic and former head of the toxicology division at Columbia University Medical Center.
The FDA said the drug is not currently approved for sale, and it will require a follow-up study for approval. It said the clinical trials would continue until a decision is made whether the products would have a similar risk of harm or be more effective.
The drugmaker said the FDA is currently consulting with pharmaceutical companies and is investigating potential new applications to sell the products to consumers.
The FDA said it has not received any reports of adverse events related to the approved uses of the drugs.
Sandra F. Boudreau, president of the National Association of Boards of Pharmacy and former FDA chair, said her organization was confident that the drug was safe and effective.
“There are a lot of people who are going to pay for this,” she said. “We have to make sure that it’s right for us, that it’s right for our patients, that we’re making it as a public health measure.”
The company said it would make a decision on whether to approve the drugs to consumers, even though there is no evidence that the drug has serious side effects.
“I don’t know what is going to happen,” said David C. Kuntz, vice president and general counsel at the National Association of Boards of Pharmacy, which represents drugmakers in the industry.
The company said the FDA is reviewing the data from the clinical trials and is working on a final decision soon.
The FDA will review the data to determine whether it would be an appropriate decision for the companies to make.
“We are having problems getting this done,” said Dr. Mark W. Hochberg, chief medical officer for Pfizer, which makes Pfizer's Viagra, and the company’s other products, including Lipitor and Zoloft.
The FDA said it will continue to evaluate the data and will take further action. It will also advise on the safety and effectiveness of the products and will make recommendations on whether additional studies can be conducted.
A spokeswoman for Pfizer said: “Pfizer's recent actions in the FDA are the company’s first steps to ensure the safety and effectiveness of its products.”
The FDA said it will take the actions it took in the first quarter of 2016 and will continue to monitor the safety and effectiveness of the products.
In the first week of 2016, the FDA said it would review its review of the data and will make recommendations on whether additional studies can be conducted.
The company will have an official comment at 1 p.m. Monday for the company to review the data and make recommendations.
“The FDA is committed to a sound and safe and effective product,” said Dr. Mark E. McAdams, the company's director of public affairs.
Originally Published: February 13, 2018 at 12:00 AM EST
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Sildenafil citrate, commonly known by the brand name, is a prescription-only medicine used to treat erectile dysfunction (ED) in adult men. It works by improving blood flow to the penis, helping to achieve and maintain an erection during sexual activity.
Sildenafil is available in 25mg, 50mg, and 100mg strengths.
Sildenafil has been shown to be effective in up to 80% of men with ED, with effects typically noticeable within 30 to 60 minutes, and lasting for up to 4–5 hours.
Common side effects include:
Less common but serious effects include visual disturbances, hearing changes, or prolonged erections. Seek medical attention if severe or persistent side effects occur.
Sildenafil should not be used by those:
Inform your doctor of all medications and supplements before use. Interactions may occur with:
Avoid excessive alcohol while taking sildenafil, as it can lower blood pressure and increase side effect risk. Use with caution if you have any heart-related conditions.
Sildenafil is available by prescription only in the UK.
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