Mylan Inc. MYL today
announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has
launched Fenofibric Acid Delayed-release Capsules, 45 mg and 135 mg.
Fenofibric Acid Delayed-release Capsules, 45 mg and 135 mg, are the generic
version of Abbott's Trilipix® Capsules, which are indicated as an adjunct to
diet in combination with a statin to reduce triglyceride and increase
high-density lipoprotein cholesterol in patients with mixed dyslipidemia and
CHD or a CHD risk equivalent who are on optimal statin therapy to achieve
their low-density lipoprotein cholesterol goal. Mylan received final approval
from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug
Application (ANDA) for this product.
Fenofibric Acid Delayed-release Capsules, 45 mg and 135 mg, had U.S. sales of
approximately $553.6 million for the 12 months ending March 31, 2013,
according to IMS Health.
Currently, Mylan has 174 ANDAs pending FDA approval representing $83.2 billion
in annual sales, according to IMS Health. Thirty-six of these pending ANDAs
are potential first-to-file opportunities, representing $22.9 billion in
annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS
Health.
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