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Sildenafil, sold under the brand name Viagra among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. [4] [8] It is also sometimes used off-label for the treatment of certain symptoms in secondary Raynaud's phenomenon. [9]
After further trials, sildenafil citrate was approved by the Food and Drug Administration (FDA) in 1998 as the active ingredient in brand name Viagra, now a very well-known drug for ED.
* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).
Chemical structure of sildenafil (Viagra), the prototypical PDE5 inhibitor. A phosphodiesterase type 5 inhibitor (PDE5 inhibitor) is a vasodilating drug that works by blocking the degradative action of cGMP-specific phosphodiesterase type 5 (PDE5) on cyclic GMP in the smooth muscle cells lining the blood vessels supplying various tissues.
Sildenafil Drug Interactions A word on sildenafil drug interactions: Mixing antihypertensive prescription drugs (hypertension meds) with Viagra may cause low blood pressure.
The PDUFA date thus serves as a 'best estimate' of when a decision on a New Drug Application or a Biologics License Application would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL). The PDUFA date may be extended by the Food and Drug Administration in certain circumstances. [6]
For example, in clinical trials of sildenafil, 28 percent of men reported headache (by far the most common side effect) at a dosage of 100mg, compared to just 16 percent of men who used 25mg and ...
The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)