|Mar 16, 2020||Clarus Therapeutics Announces Financing to Support the Commercial Launch and Availability of JATENZO® (testosterone undecanoate) Capsules, CIII for the Treatment of Hypogonadism|
|Feb 10, 2020||Clarus Therapeutics Announces Commercial Launch and Availability of JATENZO® (testosterone undecanoate) Capsules, CIII for the Treatment of Hypogonadism|
|Dec 11, 2019||Clarus Therapeutics Expands Executive Team in Preparation for Landmark Launch of JATENZO® (testosterone undecanoate) Capsules CIII|
|Aug 26, 2019||Lipocine Withdraws Preliminary Injunction Threat Against Marketing of Clarus Therapeutics' JATENZO® Product: Trial Date Set for August 2020|
|Aug 19, 2019||Clarus Therapeutics Announces FDA Award of 3-Year Market Exclusivity for Jatenzo®|
|Apr 03, 2019||Clarus Therapeutics Refutes Patent Infringement Complaint|
|Mar 27, 2019||Clarus Therapeutics Receives U.S. FDA Approval of JATENZO® (Testosterone Undecanoate Capsules for Oral Use) (CIII) for Testosterone Replacement Therapy in Certain Adult Men|
|Jun 26, 2017||Clarus Re-submits JATENZO NDA Following Positive Results of inTUne Trial|
|Oct 13, 2016||Clarus Therapeutics Provides Update on Patent Infringement Lawsuit Against Lipocine's Oral Product for Testosterone Replacement Therapy|
|May 17, 2016||Clarus Therapeutics Initiates Phase 3 Clinical Trial of Oral Testosterone Replacement Therapy|
|Nov 02, 2015||Clarus Therapeutics, Inc. Seeks Injunction Against the Marketing of Lipocine, Inc.'s Oral Product for Testosterone Replacement Therapy (LPCN 1021)|
|Sep 18, 2014||Clarus Therapeutics Reports FDA Advisory Committees Vote on REXTORO(TM) for Low Testosterone in Men|
|Jul 21, 2014||Clarus Therapeutics Expands Board of Directors with Appointment of Two Pharmaceutical Industry Veterans|
|Jun 22, 2014||Clarus Therapeutics Presents Phase 3 Data for REXTORO® for Men with Hypogonadism|
|Jun 12, 2014||Clarus Therapeutics Secures $31.5 Million in Financing|
|May 28, 2014||Clarus Therapeutics to Present Phase 3 Data for REXTORO(R) at ICE/ENDO 2014|
|May 21, 2014||Clarus Therapeutics Appoints Patrick Shea Chief Commercial Officer|
|Jan 13, 2014||Clarus Therapeutics Submits New Drug Application for Rextoro (formerly CLR-610) for the Treatment of Low Testosterone|
|Jan 01, 2014||Clarus Therapeutics Presents at 32nd Annual J.P. Morgan Healthcare Conference|
|Jul 01, 2013||Clarus Therapeutics Bolsters Executive Team with Addition of Chief Medical and Chief Scientific Officers|
|Sep 25, 2012||Clarus Therapeutics Top-line Results Show Oral Testosterone Replacement Candidate, CLR-610, Meets Phase 3 Study Primary Efficacy Endpoint|
|Sep 19, 2012||Clarus Therapeutics Strengthens Patent Estate with Issuance of a U.S. Patent Directed to Formulations and Method of Use of Clarus' Oral Testosterone Product|
|May 01, 2012||Clarus Therapeutics Completes Patient Enrollment in Phase 3 Study of its Proprietary Oral Testosterone Replacement Therapy|
JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Limitation of use
Safety and efficacy of JATENZO in males less than 18 years old have not been established.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASES IN BLOOD PRESSURE
JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies as JATENZO has not been established for these conditions and there is a risk of increased blood pressure with JATENZO that can increase the risk of MACE.
WARNINGS AND PRECAUTIONS
The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).
USE IN SPECIFIC POPULATIONS
The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.
Please click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
JATENZO is a registered trademark of Clarus Therapeutics.