Complete Response Letters
Sun Pharma Global FZE: Levetiracetam
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Mar 29, 2013
Levetiracetam Extended-release Tablets, 1000mg and 1500mg.
CRL_NDA204417_20130329:p1:s14We acknowledge that the data from your bioequivalence (BE) studies establish that your product is bioequivalent to Keppra XR in the fasted state.
CRL_NDA204417_20130329:p1:s23FDA review of the Reference Listed Drug (RLD); the Agency can only rely on the specific information contained in the label of the RLD.
CRL_NDA204417_20130329:p1:s38XR, we cannot approve your 1000 mg tablet based on a waiver of the bioequivalence requirement for that strength.
CRL_NDA204417_20130329:p1:s42The labeling of the RLD does not have a statement limiting alcohol use.
CRL_NDA204417_20130329:p1:s448. Provide English translations of current approved foreign labeling not previously submitted.
CRL_NDA204417_20130329:p2:s26More Complete Response Letters
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