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Andrx Corporation
ANDA filings pending for Concerta; Wellbutrin marketing rights relinquished
April 22nd, 2004
Andrx Corporation (ADRX) announced that it has pending abbreviated new drug applications (ANDAs) with the U.S. Food and Drug Administration (FDA) for generic versions of Concerta (methylphenidate hydrochloride) Extended-Release Tablets, 18mg, 27mg, 36mg and 54mg strengths. Though the pediatric exclusivity period for Concerta was reportedly due to expire on March 17, 2004, McNeil Consumer & Specialty Pharmaceuticals, which markets Concerta, has filed a Citizen Petition with the FDA that affects the timing of, and potentially the approval criteria for, ANDA approvals relating to generic Concerta. Andrx also announced that it has relinquished its right...
Source: FDA Law Weekly (2004-04-22)
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