Fera Pharmaceuticals and Oakwood Labs Announce ANDA Approval of Levothyroxine Sodium for Injection

NEW YORK–(BUSINESS WIRE)–Fera Pharmaceuticals and Oakwood Laboratories are pleased to announce
that on June 29, 2016, the FDA approved their ANDA for 100 and 500 mcg
Levothyroxine Sodium for Injection. The ANDA is owned jointly by Fera
and Oakwood.
Indicated for myxedema coma, the companies believe the product will
enjoy 180-day generic drug exclusivity upon launch.
Frank DellaFera, President at Fera, stated, “The approval of this ANDA
is an important milestone at Fera and also demonstrates FDA efficiency
in handling a file granted expedited review.” Mark T. Smith, President
at Oakwood, indicated, “Obtaining first approval of this product is a
tribute to the Oakwood product development group’s diligence and
expertise.”
According to IMS Health, sales for the Reference Listed Drug, Fresenius
Kabi’s Levothyroxine, were over $93,000,000 during the twelve months
ending May 2016.
About Levothyroxine Sodium for Injection
Warnings for Levothyroxine Sodium for Injection include risk of cardiac
complications in elderly and in patients with cardiovascular disease and
need for concomitant glucocorticoids and monitoring for other diseases
in patients with endocrine disorders. Levothyroxine Sodium for Injection
is not indicated for treatment of obesity. Excessive doses of
levothyroxine can predispose to signs and symptoms compatible with
hyperthyroidism. The signs and symptoms of thyrotoxicosis include, but
are not limited to: exophthalmic goiter, weight loss, increased
appetite, palpitations, nervousness, diarrhea, abdominal cramps,
sweating, tachycardia, increased pulse and blood pressure, cardiac
arrhythmias, angina pectoris, tremors, insomnia, heat intolerance,
fever, and menstrual irregularities.
About Fera Pharmaceuticals, LLC
Fera Pharmaceuticals is a privately held company. The company goal is
to realize opportunities via acquisitions, in-licensing, developing and
marketing abbreviated new drug applications (ANDAs), new drug
applications (NDAs) and 505(b)(2) NDA products. For more information
visit www.ferapharma.com.
About Oakwood Laboratories, LLC
Oakwood Laboratories, headquartered near Cleveland, Ohio, is an
emerging, technology-based specialty pharmaceutical company focused on
hard-to-develop generic, quasi-generic, and sustained-release injectable
pharmaceuticals, as well as contract manufacturing. For more information
visit www.oakwoodlabs.com