Perrigo and Teva Lead Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Perrigo and Teva.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday March 1, 2017 to Tuesday March 7, 2017.
Perrigo Gains FDA OK for Generic Testosterone Therapy
Perrigo has received final approval from the US Food and Drug Administration for its abbreviated new drug application referencing Eli Lilly and Company’s Axiron topical solution, 30 mg/1.5 mL (testosterone topical solution, 30 mg/1.5 mL).
Axiron topical solution, 30 mg/1.5 mL is indicated for treating adult males who have low or no testosterone due to certain medical conditions. Annual sales for the product for the 12 months ending January 2017 were approximately $254 million, according to Perrigo.
Teva Launches Generic Anti-Depressant
Teva Pharmaceutical Industries has launched in the US its generic version of Pfizer’s Pristiq (desvenlafaxine) extended-release tablets, 25 mg, 50 mg, and 100 mg, an anti-depressant. Desvenlafaxine extended-release tablets are a serotonin and norepinephrine reuptake inhibitor indicated for treating major depressive disorder.
Desvenlafaxine extended-release tablets boosts Teva’s portfolio of anti-depressant products. Pristiq had annual sales of approximately $883 million in the US according to QuintilesIMS data as of December 2016 and as cited by Teva.
Source: Teva Pharmaceutical Industres
EC OKs Actelion’s Topical Lymphoma Drug
Actelion, an Allschwil, Switzerland-headquartered biopharmaceutical company, has received approval from the European Commission for the use of Ledaga (chlormethine gel) 160 micrograms/gram, a topical drug for treating mycosis fungoides-type cutaneous T-cell lymphoma, a rare, potentially life-threatening immune system cancer that is chronic and usually progresses slowly.
Actelion is planning to launch Ledaga in the European Union as soon as possible. The company has agreed to a list of post-approval measures with the Committee for Medical Products for Human Use of the European Medicines Agency. Subject to fulfilling the agreed commitments and achieving market access in various countries, a potential first European launch of Ledaga is not expected before January 2018.
Ledaga is an alkylating drug formulated as a topical, once-daily, colorless gel. Chlormethine gel, the active ingredient in Ledaga, is marketed in the US under the brand name Valchlor (mechlorethamine) and has been commercially available in the US since 2013 and in Israel since 2016 through a special import authorization procedure. In France, the drug is commercially available under a temporary authorization for use program initiated during the second half of 2014.