U.S. Pharmacist

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Mylan Files ANDA for Chemo Drug; Sued by Roche

By Staff


5/19/2009

US Pharm. 2009;34(5):36-38. 

Mylan Inc. and its subsidary Mylan Pharmaceuticals Inc. have been sued by Hoffmann-LaRoche Inc. in connection with the filing of an ANDA with the FDA for capecitabine tablets, 150 mg and 500 mg, the generic version of Xeloda Tablets, a chemotherapy treatment for breast and colorectal cancer. Mylan believes it is the first company to have filed a substantially complete ANDA containing a paragraph IV certification for the product and expects to qualify for 180 days of sole marketing exclusivity once final FDAapproval has been obtained.  

Hoffmann-La Roche filed a lawsuit on April 8, 2009, in the U.S. District Court for the District of New Jersey alleging infringement of U.S. Patent No. 5,472,949.
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U.S. Pharmacist is a monthly journal dedicated to providing the nation's pharmacists with up-to-date, authoritative, peer-reviewed clinical articles relevant to contemporary pharmacy practice in a variety of settings, including community pharmacy, hospitals, managed care systems, ambulatory care clinics, home care organizations, long-term care facilities, industry and academia. The publication is also useful to pharmacy technicians, students, other health professionals and individuals interested in health management. Pharmacists licensed in the U.S. can earn Continuing Education credits through Postgraduate Healthcare Education, LLC, accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

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