FDA declines approval of Lipocine’s oral drug Tlando for third time
Category: #health  By Mateen Dalal  Date: 2019-11-13
  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn

FDA declines approval of Lipocine’s oral drug Tlando for third time

FDA declines approval of Lipocine’s oral drug Tlando for third time

Reportedly, the oral drug Tlando was first declined  approval by FDA in the year 2016.

The U.S. Food and Drug Administration (FDA)  declined the approval of oral drug Tlando, developed by Lipocine Inc. for the third time. The drug has been developed to treat a condition, which results in lesser production of male sex hormone. Tlando has been developed to restore normal testosterone levels in male patients with absence or deficiency of testosterone.

This rejection of approval has led the shares of the company to drop by 34%.

As per reliable sources, FDA informed through a letter that the application can not be accepted in its present form as the trial conducted Lipocine could not meet three secondary goals.  These three objectives were designed to evaluate if higher levels of testosterone could risk safety of patients.

Apparently, the decision is the third regulatory setback for Lipocine's Tlando over the period of three years.

Reportedly, the oral drug Tlando was first declined approval by FDA in the year 2016. Later, in 2018, approval for the same  was rejected again for a dosing irregularity. The regulatory body requested for more information to assess whether or not the drug could raise blood pressure in patients.

Lipocine has been struggling to introducing Tlando as a safer substitute to topical therapies, which can cause accidental transference of testosterone.

Sources close to the matter informed that FDA did not find any specific issues related to the chemical composition and manufacturing of Tlando. Lipocine reportedly stated that the company is looking forward to requesting a meeting with FDA soon to ascertain the necessary steps required  for the approval of the drug.

For the record, the U.S. Census Bureau anticipates that around 21.7 million male population in the United States aged between 30-79 years may experience low testosterone levels. The condition can cause decreased muscle mass, loss of libido, depression, and fatigue.
 

Source link:

https://www.thisismoney.co.uk/wires/reuters/article-7672717/FDA-rejects-Lipocines-testosterone-drug-time.html

  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal     twitter

Mateen Dalal

A qualified electronics and telecommunication engineer, Mateen Dalal embarked on his professional journey working as a quality and test engineer. Harnessing his passion for content creation however, Mateen pens down industry-rich articles for ReportsGO.com and a few o...

Read More..

More News By Mateen Dalal

China unveils plans to reinforce stringent safety standards for EVs

China unveils plans to reinforce stringent safety standards for EVs

By Mateen Dalal

This news comes amid rising incidences of battery fires and breaks failures. China will require automakers to have a 24-hour emergency response system to address major accidents. China is planning to reinforce strict safety standards for electri...

Facebook testing new option for cross-posting content to Instagram

Facebook testing new option for cross-posting content to Instagram

By Mateen Dalal

Facebook, Inc is reportedly testing an option that will allow users to cross-post their photos, videos, and other posts on their Instagram. It already has the feature to let people cross-post their Instagram content to Facebook. This upcoming featur...

General Motors to recoup USD 1.9 Bn from LG spent on Bolt EV recall

General Motors to recoup USD 1.9 Bn from LG spent on Bolt EV recall

By Mateen Dalal

GM will recover almost all the costs from the recall of its Bolt EV models. Despite the EV battery manufacturing mishap from LG, the two companies will continue to work together. General Motors (GM) has agreed to recover around USD 1.9 billion f...