By RTT News, March 06, 2014, 07:29:00 AM EDT
(RTTNews.com) - Endo International plc. (ENDP, ENL.TO) announced that its operating company Endo Pharmaceuticals Inc. received U.S. Food and Drug Administration or FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone.
The company stated that AVEED is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March.
The approval of AVEED is based on data from an 84-week Phase 3 trial of hypogonadal men in the U.S.Men enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL.
According to the company, AVEED is available as a single-use vial. Dosage titration is not necessary. Following the first intramuscular injection of 3 mL of AVEED (750 mg), a second 3 mL dose is injected 4 weeks later, and then 3 mL is injected every 10 weeks thereafter. AVEED is prescribed and administered by trained healthcare providers in a doctor's office, clinic, or hospital.
AVEED contains testosterone undecanoate, which Endo licensed through its subsidiary Endo Pharmaceuticals Solutions Inc. from Bayer Pharma AG. Outside the U.S., Bayer Pharma AG and its subsidiaries have been marketing testosterone undecanoate injections since 2003.
For comments and feedback: contact editorial@rttnews.com
Originally posted here:
Endo: FDA Oks AVEED Injection For Treatment Of Adult Men With Hypogonadism
- Testosterone, Memory and Diabetes: What’s the Link? - June 26th, 2022
- Female Hypogonadism Symptoms | eHow - May 18th, 2021
- Low T - My life was falling apart because I had low testosterone - April 25th, 2021
- Hypogonadism - April 11th, 2021
- Testosterone cream and gel for supplementation treating hypogonadism - March 13th, 2021
- Testosterone Treatments May Alleviate Negative Effects of Type-Two Diabetes - December 8th, 2020
- More than 152 Million Men Suffer from Hypogonadism and Low Testosterone - November 26th, 2020
- Clomiphene Citrate for Low-T - October 28th, 2020
- NATESTO (testosterone) Nasal Spray - October 27th, 2020
- Risk Factors for and Causes of Male Hypogonadism - October 11th, 2020
- What Is Male Hypogonadism - August 14th, 2020
- Excessive Use of Tylenol / Acetaminophen May Negatively Affect Testosterone Levels in Unborn Boys - August 1st, 2020
- Ordering Testosterone Replacement Therapy (TRT) – Buy it Online! - May 8th, 2020
- Hypogonadism: Treatment, Diagnosis, and Prognosis - April 16th, 2020
- Testosterone Replacement Beneficial for Modern Men? - February 11th, 2020
- HIV and Testosterone Deficiency - verywell.com - July 17th, 2016
- Hypogonadism - UT Medical Center - July 17th, 2016
- Hypogonadism - Definition, Causes, Symptoms and Treatment - July 17th, 2016
- Lipocine - Hypogonadism - July 17th, 2016
- Hypogonadism - Risks, Symptoms and Leading Causes | Treato - July 17th, 2016
- Hypogonadism and Hypogonadism Resources - What is ... - July 17th, 2016
- Male Hypogonadism - Genitourinary Disorders - Merck ... - July 9th, 2016
- Male - Hypogonadism -- Low T Treatment Help!? - Drugs.com - May 6th, 2016
- Hypogonadism Causes Infertility. Learn how to detect and ... - May 6th, 2016
- BodyLogicMD - Hypogonadism (Low Testosterone in Men) - February 8th, 2016
- Hypogonadism | Disorders | Knowledge Base - August 26th, 2015
- hypogonadism | pathology | Britannica.com - July 22nd, 2015
- Male hypogonadism Tests and diagnosis - Mayo Clinic - May 23rd, 2015
- Hypogonadism (Medical Condition) - Video - April 21st, 2015
- Treatment Options for Hypogonadism - Healthline - April 4th, 2015
- Hypergonadotropic hypogonadism - Wikipedia, the free ... - March 23rd, 2015
- Testosterone treatment of male hypogonadism - UpToDate - March 23rd, 2015
- Statins may lower testosterone and libido - March 16th, 2015
- Hypogonadotropic Hypogonadism - Pipeline Review, H1 2015 - March 13th, 2015
- Biomarker monitors testosterone therapy for osteoporosis - March 12th, 2015
- The effect of hypogonadism and testosterone-enhancing therapy - Video - March 5th, 2015
- Causes of secondary hypogonadism in males - March 2nd, 2015
- Male hypogonadism: symptoms, cause, treatment, risk ... - February 18th, 2015
- Male Hypogonadism 1/28/15 - Video - January 31st, 2015
- What is Hypogonadism - Symptoms and Treatment | Hormone ... - January 30th, 2015
- Auxilium Announces Results from Special Meeting of Stockholders - January 28th, 2015
- Male hypogonadism pathophysiology - Video - January 14th, 2015
- Endo to Acquire Rights to Testosterone Nasal Gel Natesto - Analyst Blog - November 26th, 2014
- Testosterone Deficiency (Hypogonadism) Overview ... - November 23rd, 2014
- Male Hypogonadism Therapeutic Pipeline Industry Review, H2 2014 - Video - November 7th, 2014
- Hypogonadism in men living with HIV - Video - November 7th, 2014
- Will Repros (RPRX) Miss Estimates This Earnings Season? - Analyst Blog - November 5th, 2014
- Urology Care Foundation - Urology A-Z - Low Testosterone - November 3rd, 2014
- Male Hypogonadism: Male Reproductive Endocrinology: Merck ... - October 28th, 2014
- Hypogonadism Wikipedia - October 28th, 2014
- Hypogonadism No Moustache! No Beard!! - October 28th, 2014
- Apricus expands development pipeline with the in-licensing of US rights for fispemifene, a phase 2b ready asset, from ... - October 21st, 2014
- Apricus expands development pipeline with in-licensing of US rights for fispemifene - October 21st, 2014
- The Wall Street Journal: Repros Therapeutics shares drop on drug application setback - October 18th, 2014
- Repros Therapeutics Analyst Brief Report; Androxal(R) Achieves Superiority in Top Line Analysis by Small Cap Street ... - September 30th, 2014
- Repros Reports Encouraging Late-Stage Data on Androxal - Analyst Blog - August 28th, 2014
- Repros Therapeutics Q2 Loss a Penny Wider than Expected - Analyst Blog - August 12th, 2014
- Prevalence, Diagnosis and Treatment of Hypogonadism in ... - April 30th, 2014
- Repros Completes Enrollment for Androxal Study - Analyst Blog - April 16th, 2014
- VLog #127 Frances Explains Hypogonadism. - Video - April 7th, 2014
- Hypogonadism: Types, Causes, & Symptoms - Medical ... - April 6th, 2014
- Male hypogonadism Symptoms - Diseases and Conditions ... - April 2nd, 2014
- Update on Endo's Product Portfolio - Analyst Blog - March 11th, 2014
- Unit Project 1 Hypogonadotropic hypogonadism - Video - March 8th, 2014
- Hypogonadism | Medscape - Latest Medical News, Clinical ... - February 23rd, 2014
- Hypogonadism : Types, Causes, & Symptoms - Healthline - February 17th, 2014
- Low Testosterone (Hypogonadism) in Men - Video - February 14th, 2014
- Hypogonadism: Types, Causes, & Symptoms Healthline - February 14th, 2014
- Testosterone Therapy Not Always Good for Older Men - February 11th, 2014
- Endocrine Society calls for large-scale studies to evaluate testosterone therapy risks - February 8th, 2014
- Study Finds Potential Heart Risks from Testosterone Therapy - February 3rd, 2014
- Hypogonadism - SharedJourney - January 23rd, 2014
- Hypogonadism | Medscape - Latest Medical News, Clinical Trials ... - December 30th, 2013
- Hypogonadism - HealthCentral - December 24th, 2013
- Hypogonadism - December 23rd, 2013
- Hypogonadism - Medscape Reference - December 21st, 2013
- Audio-Digest Foundation Announces the Release of Oncology Volume 04, Issue 16: Highlights from Future Directions ... - December 15th, 2013
- Male hypogonadism: Symptoms - MayoClinic.com - December 12th, 2013
- Exciting medical advances using HRT - December 12th, 2013
- Hypogonadism - About.com Men's Health - December 2nd, 2013
Word Count: 276