There is a single report of acute overdosage after parenteral administration of an approved testosterone product in the literature. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH. There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing FORTESTA to determine whether efficacy in those over 65 years of age differs from younger subjects.
The metered dose pump is capable of dispensing 120 metered pump actuations. To obtain a full first dose, it is necessary to prime the canister pump. In addition, serum testosterone concentration should be assessed periodically thereafter. The dose can be adjusted between a minimum of 10 mg of testosterone and a maximum of 70 mg of testosterone. Prior to initiating, FORTESTA confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least 2 separate days and that these serum testosterone concentrations are below the normal range.
Check with your physician for additional information about side effects. This document does not contain all possible side effects and others may occur. Get medical help right away, if you have any of the symptoms listed above.
Accordingly, the Agency will continue to list FORTESTA (testosterone) gel, 10 mg/0.5 gm actuation, in the "Discontinued Drug Product List" section of the Orange Book. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of FORTESTA (testosterone) gel, 10 mg/0.5 gm actuation, from sale. The petitioner has identified no data or other information suggesting that this drug product was withdrawn for reasons of safety or effectiveness. Encube Ethicals Private Limited submitted a citizen petition dated May 22, 2024 (Docket No. FDA-2024-P-2515), under 21 CFR 10.30, requesting that the Agency determine whether FORTESTA (testosterone) gel, 10 mg/0.5 gm actuation, was withdrawn from sale for reasons of safety or effectiveness. Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product.
This is not a complete list of possible side effects. A very serious allergic reaction to this product is rare. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur. Be prepared to treat low blood sugar while you are using this medication. Your doctor may control your blood pressure with medication.
FORTESTA is supplied in 60 g canisters with a metered dose pump that delivers 10 mg of testosterone per complete pump actuation. FORTESTA (testosterone) Gel for topical use only, is supplied in a metered-dose pump. Avoid fire, flames, or smoking until the gel has dried since alcohol based products, including FORTESTA, are flammable. The recommended starting dose of FORTESTA is 40 mg of testosterone (4 pump actuations) applied once daily to the thighs in the morning. Our Fortesta Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Fortesta is available in a gel at a concentration of 10 mg testosterone per pump. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Each pump actuation provides 10 mg of testosterone and each container is capable of dispensing 120 pump actuations. Fortesta is a clear, colorless, odorless, gel containing testosterone. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with Fortesta. Fortesta may cause serious adverse reactions in nursing infants. The starting dose of Fortesta is 40 mg (4 pumps) applied topically once daily in the morning. We have also independently evaluated relevant literature and data for possible post-marketing adverse events.
Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. The "Discontinued Drug Product List" delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.
Once the application site is dry, the site should be covered with clothing see CLINICAL PHARMACOLOGY. FORTESTA should be applied directly to clean, dry, intact skin of the front and inner thighs. Table 1 describes the dose adjustments required at each titration step. The active pharmacologic ingredient in Fortesta is testosterone. In pregnant or breastfeeding women, Fortesta may cause fetal harm.