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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
The efficacy, safety, and outcomes of testosterone use among transgender men patients
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<blockquote data-quote="madman" data-source="post: 238957" data-attributes="member: 13851"><p>Yes.</p><p></p><p>Androgel holds that title among the transdermal T-gels.</p><p></p><p>Delatestryl was approved in 1953 and Depo-T in 1979.</p><p></p><p>Methyltestosterone was the first oral to hit the market in the early 70s and although it is still being manufactured in the US it is rarely prescribed due to its high potential for liver toxicity.</p><p></p><p>Jatenzo was the first non-c17 alpha alkylated oral on the US market.</p><p></p><p></p><p></p><p></p><p>[URL unfurl="true"]https://www.globenewswire.com/en/news-release/2019/03/27/1779866/19989/en/Clarus-Therapeutics-Receives-U-S-FDA-Approval-of-JATENZO-Testosterone-Undecanoate-Capsules-for-Oral-Use-CIII-for-Testosterone-Replacement-Therapy-in-Certain-Adult-Men.html[/URL]</p><p></p><p><em><strong>*JATENZO is a first-in-class proprietary softgel oral formulation, and the first oral testosterone medicine approved in more than 60 years</strong></em></p><p></p><p></p><p>[URL unfurl="true"]https://www.urologytimes.com/view/dr-newmark-provides-updates-on-fda-approved-oral-testosterone-undecanoate[/URL]</p><p></p><p><strong><em>*JATENZO is the first oral testosterone replacement therapy that's been approved by the FDA in over 40 years. The previous product, methyl testosterone, was known to cause hepatotoxicity and therefore is almost never used today. JATENZO is formulated as a self-emulsifying drug delivery system and avoids the first pass effect through the liver</em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Androgel 1%</strong> -2000</p><p><strong>Testim 1%</strong> - 2002</p><p><strong>Andriol</strong> - never approved in the US</p><p><strong>Delatestryl</strong> - 1953</p><p><strong>Depo-Testosterone</strong> - 1979</p><p></p><p></p><p></p><p></p><p></p><p><strong>B. FDA Approval of Depo-Testosterone</strong></p><p><strong></strong></p><p><strong><em>In 1953, the Food and Drug Administration approved a new drug, Delatestryl, as a testosterone replacement injection. Its original purpose, according to the new drug application filed on its behalf, was to treat men whose bodies did not produce enough testosterone naturally. </em></strong><em>This NDA came before many of today’s regulatory requirements, though Delatestryl later passed effectiveness screening in the 1960s as required under the then-new Drug Efficacy Study Implementation program.</em></p><p><em></em></p><p><em><strong>In 1979, the FDA approved the Upjohn Company’s abbreviated new drug application (ANDA) for Depo-Testosterone, a testosterone injection similar to Delatestryl.</strong> <strong>Depo-T, as the product is still called, produced safety and effectiveness results equivalent to those of Delatestryl. </strong>Under the drug approval process at the time, similar results sufficed for streamlined ANDA approval. But because of a slight difference in its physical composition that made it not quite the same as Delatestryl, after the 1984 statutory changes were implemented, Depo-T became the reference listed drug (RLD) for its precise kind of testosterone injection. This meant that any drugs seeking to follow in Depo-T’s footsteps had to demonstrate bioequivalence to (i.e., that they were the same as) Depo-T to qualify for the streamlined approval process of an abbreviated new drug application. See above at 4; see also 21 U.S.C. § 355(j)(2)(A)(iv); 21 C.F.R. § 314.3(b). When these lawsuits were filed, defendant Pfizer had taken over the production and marketing of Depo-T, and the drug remained the reference listed drug. <strong>More than half a dozen other testosterone drugs have followed Depo-T’s lead since its approval in 1979.</strong></em></p><p><em></em></p><p><em></em></p><p><em></em></p></blockquote><p></p>
[QUOTE="madman, post: 238957, member: 13851"] Yes. Androgel holds that title among the transdermal T-gels. Delatestryl was approved in 1953 and Depo-T in 1979. Methyltestosterone was the first oral to hit the market in the early 70s and although it is still being manufactured in the US it is rarely prescribed due to its high potential for liver toxicity. Jatenzo was the first non-c17 alpha alkylated oral on the US market. [URL unfurl="true"]https://www.globenewswire.com/en/news-release/2019/03/27/1779866/19989/en/Clarus-Therapeutics-Receives-U-S-FDA-Approval-of-JATENZO-Testosterone-Undecanoate-Capsules-for-Oral-Use-CIII-for-Testosterone-Replacement-Therapy-in-Certain-Adult-Men.html[/URL] [I][B]*JATENZO is a first-in-class proprietary softgel oral formulation, and the first oral testosterone medicine approved in more than 60 years[/B][/I] [URL unfurl="true"]https://www.urologytimes.com/view/dr-newmark-provides-updates-on-fda-approved-oral-testosterone-undecanoate[/URL] [B][I]*JATENZO is the first oral testosterone replacement therapy that's been approved by the FDA in over 40 years. The previous product, methyl testosterone, was known to cause hepatotoxicity and therefore is almost never used today. JATENZO is formulated as a self-emulsifying drug delivery system and avoids the first pass effect through the liver[/I] Androgel 1%[/B] -2000 [B]Testim 1%[/B] - 2002 [B]Andriol[/B] - never approved in the US [B]Delatestryl[/B] - 1953 [B]Depo-Testosterone[/B] - 1979 [B]B. FDA Approval of Depo-Testosterone [I]In 1953, the Food and Drug Administration approved a new drug, Delatestryl, as a testosterone replacement injection. Its original purpose, according to the new drug application filed on its behalf, was to treat men whose bodies did not produce enough testosterone naturally. [/I][/B][I]This NDA came before many of today’s regulatory requirements, though Delatestryl later passed effectiveness screening in the 1960s as required under the then-new Drug Efficacy Study Implementation program. [B]In 1979, the FDA approved the Upjohn Company’s abbreviated new drug application (ANDA) for Depo-Testosterone, a testosterone injection similar to Delatestryl.[/B] [B]Depo-T, as the product is still called, produced safety and effectiveness results equivalent to those of Delatestryl. [/B]Under the drug approval process at the time, similar results sufficed for streamlined ANDA approval. But because of a slight difference in its physical composition that made it not quite the same as Delatestryl, after the 1984 statutory changes were implemented, Depo-T became the reference listed drug (RLD) for its precise kind of testosterone injection. This meant that any drugs seeking to follow in Depo-T’s footsteps had to demonstrate bioequivalence to (i.e., that they were the same as) Depo-T to qualify for the streamlined approval process of an abbreviated new drug application. See above at 4; see also 21 U.S.C. § 355(j)(2)(A)(iv); 21 C.F.R. § 314.3(b). When these lawsuits were filed, defendant Pfizer had taken over the production and marketing of Depo-T, and the drug remained the reference listed drug. [B]More than half a dozen other testosterone drugs have followed Depo-T’s lead since its approval in 1979.[/B] [/I] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
The efficacy, safety, and outcomes of testosterone use among transgender men patients
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