Mylan debuts generic Antara; FDA approves generics of Actavis' Suboxone, Lupin's Suprax and Zydus' Zantac

US generic firm Mylan (Nasdaq: MYL) says its subsidiary Mylan Pharmaceuticals has begun shipping fenofibrate capsules USP, 43mg and 130mg, the generic version of Lupin Atlantis Holdings, SA's Antara capsules, which are indicated as an adjunct to diet to reduce elevated low-density lipoprotein cholesterol, total-C, triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

Fenofibrate in the mentioned dosage forms had US sales of around $60 million for the 12 months ending September 30, 2012, according to IMS Health. Mylan has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for this product.

Actavis ANDA for Suboxone cleared by FDA