Teva Pharmaceutical Industries Ltd. has announced that the US Food and Drug Administration (FDA) has approved Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington's disease (HD), a rare and fatal neurodegenerative disorder. Teva Pharmaceutical Industries Ltd is headquartered in Israel.
Indications: Austedo is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington's disease.
Dosage/administration: The starting dose is 6 mg once daily; titrate up at weekly intervals by 6 mg per day to a tolerated dose that reduces chorea, up to a maximum recommended daily dosage of 48 mg (24 mg twice daily). Total daily dosages of ≥12 mg should be administered in 2 divided doses. Tablets should be administered with food and swallowed whole; they should not be chewed, crushed, or broken.
Adverse reactions: Most common adverse reactions were somnolence, diarrhea, dry mouth, and fatigue.
Teva announces FDA approval of AUSTEDO™ (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease. [news release]. Jerusalem, Israel: Teva Pharmaceutical Industries Ltd. April 3, 2017. http://www.tevapharm.com/news/teva_announces_fda_approval_of_austedo_deutetrabenazine_tablets_for_the_treatment_of_chorea_associated_with_huntington_s_disease_04_17.aspx. Accessed April 13, 2017.
This Week's Must Reads
Guidelines for Cognitive Screening, Management of MS, Mult Scler; ePub 2018 Oct 10; Kalb, Beier, et al
Age a Critical Determent in MS Relapse Recovery, Mult Scler; ePub 2018 Oct 10; Conway, et al
Is Contrast MR Imaging Necessary for All Patients?, Am J Neuroradiol; ePub 2018 Oct 4; Mattay, et al
Link Between Physiological and Perceived Fall Risk, Arch Phys Med Rehab; 2018 Oct; Gunn, et al
Muscle Strength Key in Determining Gait Speed in MS, Mult Scler Relat Disord; ePub 2018 Oct 9; Yang, et al
Must Reads in FDA Actions
FDA Approves Tiglutik for Treatment of ALS, ITF Pharma news release; 2018 Sep 6
FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23
FDA Approves Drug for Rare Peripheral Nerve Disease, FDA Web site; 2018 Aug 10
FDA Approves Xeomin for Excessive Drooling, Merz North America news release; 2018 Jul 3
FDA Approves Epidiolex for Rare Epilepsy Forms, FDA news release: 2018 Jun 25