AbbVie, Mylan Lead News in Drug Approvals

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from AbbVie and Mylan

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday September 28, 2016 to Tuesday October 11, 2016.

AbbVie, Eisai Get Approval for New Humira Indication
AbbVie and Eisai have received approval for a new indication of Humira (adalimumab) for the treatment of non-infectious intermediate, posterior, and panuveitis. Non-infectious uveitis is a group of diseases characterized by inflammation of the uvea, the middle layer of the eye.

In Japan, AbbVie is the marketing and manufacturing authorization holder for Humira while Eisai is responsible for distribution. In addition to the new indication of non-infectious uveitis, Abbvie and Eisai are co-promoting Humira for the indications in rheumatoid arthritis, plaque psoriasis, arthropathic psoriasis, ankylosing spondylitis, and juvenile idiopathic arthritis. For the indications in the field of gastrointestinal disease, such as ulcerative colitis, Crohn’s disease, and intestinal Bechet’s disease, AbbVie and EA Pharma, a subsidiary of Eisai, are co-promoting Humira.

Source: Eisai

Mylan Launches Generic Fortamet for Diabetes
Mylan has launched metformin hydrochloride extended-release tablets USP, 500 mg and 1000 mg, an authorized generic version of Watson Pharmaceutical’s (now part of Teva Pharmaceutical Industries) Fortamet (metformin hydrochloride). Mylan received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for this product, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. Fortamet was approved by the FDA in 2004 for the management of Type 2 diabetes.

In October 2012, the generic-drug company Watson Pharmaceuticals Inc. completed its acquisition of Actavis Group; Watson then changed its corporate name to Actavis in January 2013. In March 2015, Actavis completed its approximately $70.5-billion acquisition of the specialty pharmaceutical company, Allergan, and later changed its corporate name to Allergan while retaining the Actavis name for its US and Canadian generics business. In September 2016, Allergan closed on its divestment of its generics business to Teva Pharmaceutical Industries for $40.5 billion in a deal that was first announced in July 2015.

Metformin hydrochloride extended-release tablets USP, 500 mg and 1000 mg, had US sales of approximately $770.3 million for the 12 months ending July 31, 2016, according to IMS Health and as cited by Mylan.

Source: Mylan

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