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Forest, Royalty challenge ANDA
September 25, 2013
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
Mylan has been sued by Forest Laboratories Inc., Forest Laboratories Holdings Ltd., and Royalty Pharma Collection Trust in connection with the filing of an ANDA for Milnacipran HCl Tablets 12.5 mg, 25 mg, 50 mg and 100 mg. This product is the generic version of Savella, which is indicated for the management of fibromyalgia. Mylan contends it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligib...
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