A German tablet with a US distributor
On the DailyMed Levitra label (setid 4e66ad5c-572c-4819-8b6e-6930c33cc210), the manufacturer line is Bayer HealthCare Pharmaceuticals and the country of manufacture is Germany. Distribution on that label is GlaxoSmithKline. Those are supply facts, not a ranking of erections.
The NDA was Bayer's. Drugs@FDA lists the original approval action on August 19, 2003. The public approval letter of that date clears vardenafil hydrochloride tablets for erectile dysfunction in men and records a same-day commitment to study QT interval when Levitra is combined with another drug of similar QT effect.
Sildenafil had already shown that an oral PDE5 inhibitor could be a prescription product. Vardenafil was a second molecule with its own strengths, its own food effect, and a QT paragraph the Viagra label does not carry in the same way. Tadalafil reached the US market later in 2003 with a much longer tail. Three products, three clocks.
Why the printed strengths are 2.5, 5, 10, and 20 mg
The patient information on this label lists 2.5 mg, 5 mg, 10 mg, and 20 mg. The how-supplied description prints the orange 5, 10, and 20 mg tablets. For most men the dosage section starts at 10 mg about 60 minutes before sexual activity, once a day, with room to move to 20 mg or down to 5 mg. The 2.5 mg figure is the ceiling next to ritonavir and certain other strong CYP3A4 inhibitors, not a souvenir dose.
That ladder is not a miniature Viagra. Sildenafil's usual ED range on its own label is 25, 50, and 100 mg. Smaller milligrams here do not mean a harder result, and they do not mean a safer nitrate combination. Absolute bioavailability on this label is about 15%, and the terminal half-life is about 4 to 5 hours. Those are pharmacokinetic facts. The dosing cap is still once per day.
How to apply the ladder at home is the user guide, not this history note.
The rhythm study that shipped with the carton
In 59 healthy men, 10 mg and 80 mg vardenafil and the control drug moxifloxacin 400 mg produced similar increases in QTc. At one hour, mean Fridericia-corrected change versus placebo was 8 msec after 10 mg and 10 msec after 80 mg. The 80 mg arm existed because that exposure covers a low dose sitting next to ritonavir.
Patients on Class IA antiarrhythmics (quinidine, procainamide) or Class III antiarrhythmics (amiodarone, sotalol), and patients with congenital QT prolongation, should avoid LEVITRA. A later combination study on the same label found an additive QTc effect when 10 mg was given with gatifloxacin. The millisecond table and the cohort scores live on the evidence review.
Nitrates were contraindicated from the start, regularly or intermittently, including nitric oxide donors. The label says a suitable interval for safe nitrate use after a dose has not been determined. History does not invent one.
What distribution changed, and what it left alone
GSK's name on the carton was a reach problem. Bayer could manufacture the tablet in Germany and still need a US distributor next to a household PDE5 name. Logos moved over the years. The swallow did not: one tablet, about an hour before sexual activity, sexual stimulation required, not more than once a day.
Co-promotion did not relax the nitrate contraindication, the alpha-blocker caution, or the QT avoid list. A man who still has an old printout should read the current bottle, not the 2003 sales folder.
Generics after the brand left the shelf
FDA approves Levitra tablets for erectile dysfunction in men and asks for a combination QT study.
High-fat meals cut Cmax by 18% to 50%. Half-life is about 4 to 5 hours. Dosing remains once per day.
Class IA and Class III antiarrhythmics, and congenital QT prolongation, stay off the drug.
FDA says the discontinued 5, 10, and 20 mg brand tablets were not withdrawn for safety or effectiveness.
Drugs@FDA now lists the brand Levitra tablet strengths as discontinued. In a notice published in the Federal Register on May 3, 2023, FDA determined that the 5 mg, 10 mg, and 20 mg tablets were not withdrawn from sale for reasons of safety or effectiveness. Discontinuation is a commercial fact. It is not a recall.
A generic film-coated vardenafil tablet from a state-licensed pharmacy can carry the same active ingredient and the same labeled ladder without the Bayer cross or the orange brand look. Unlicensed blisters that photograph an old orange tablet are a different risk: wrong powder, wrong milligrams. The permission gate for an online fill is the compound page.
A separate orally disintegrating 10 mg product was approved later under its own name and its own label. It is not one of the film-coated strengths on this setid, and it is not a way to melt a 5 mg or 20 mg plan into a different object.
Questions people ask next
When was Levitra approved in the United States? August 19, 2003, NDA 021400, for erectile dysfunction in men.
Who made the tablet? Bayer, manufactured in Germany on this label, with GlaxoSmithKline as the US distributor named on the same page.
Did a smaller milligram mean a stronger drug than sildenafil? No. The strengths differ. Head-to-head potency is not what this history page claims. Compare clocks and cautions, not carton size.
Why did the brand disappear? Bayer discontinued the tablets. FDA's May 3, 2023 determination says that withdrawal was not for safety or effectiveness. Generic vardenafil can still be prescribed.
Does the old orange tablet's QT warning still apply? Yes. Class IA and Class III antiarrhythmics and congenital QT prolongation remain reasons to avoid vardenafil.
Where do I read about buying it? The compound page. This URL does not quote a price.