(RTTNews) - Generic drugmaker Mylan Inc. (MYL: News ) on Thursday said its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration, or FDA, for its Abbreviated New Drug Application, or ANDA, for Liothyronine Sodium Tablets USP, 5 mcg, 25 mcg and 50 mcg.

Liothyronine Sodium Tablets are the generic version of King Pharmaceuticals' thyroid deficiency treatment Cytomel. Cytomel had total U.S. sales of about $54 million for the 12 months ending March 31 for the same strengths, according to IMS Health. Mylan has begun the shipping of this product.

As per IMS Health data, currently, Mylan has 120 ANDAs pending FDA approval representing $84.7 billion in annual brand sales. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $16.6 billion in annual brand sales, the company said quoting IMS Health.

The Mylan unit recently received approval from the FDA for its ANDA for Bicalutamide Tablets, 50 mg. Bicalutamide Tablets are the generic version of AstraZeneca Plc's (AZN) prostate cancer treatment Casodex, indicated for advanced prostrate cancer.
Last month, the FDA granted the subsidiary approval for Mylan's supplemental ANDA for Temazepam Capsules USP, 22.5 mg indicated for the short-term treatment of insomnia.

During the latest first quarter, Mylan's generics revenues, which are derived from sales in North America, Europe, the Middle East and Africa and Asia Pacific, increased to $1.03 billion from $906.7 million in the previous year quarter.

MYL closed Wednesday's regular trade at $12.36, up from the previous close of $12.35. For the past year, the stock traded in the range of $5.75-$14.94.

To receive FREE breaking news email alerts for Mylan Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: contact editorial@rttnews.com