FDA WARNING_LETTER - Noven Pharmaceuticals, Inc. - July 02, 2007

An FDA inspection of Noven Pharmaceuticals, Inc. from June to July 2007 revealed that their Daytrana® methylphenidate TD patches are adulterated under 21 U.S.C. § 351(a)(2)(B) due to non-conformity with cGMP regulations (21 CFR Part 211).

Key violations include: 1. **Failure to establish scientifically sound specifications (21 CFR § 211.160(b))**: A liner release force specification for Daytrana® patches was absent, despite historical data showing variability in peel force. The company failed to evaluate this data or justify the lack of a commercial product specification. FDA requested an explanation for not developing an "adequate database" since 2002 and further data evaluation. While Noven provided a new specification in October 2007, FDA requested rationale, data, and clarification on its relevance and incorporation into stability protocols. 2. **Failure to assure drug product quality throughout expiry (21 CFR § 211.137(a))**: Noven lacked data to assure acceptable release characteristics for the new [redacted] release liner over the 24-month expiry period, despite acknowledging age-related "tight release" and/or "adhesive transfer" issues. FDA questioned the scientific basis for the 24-month expiry given the lack of real-