Cipla - FDA’s Second CRL To IV Tramadol Put A Death Nail On The Launch Of NDA In U.S.: Prabhudas Lilladher
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Prabhudas Lilladher Report
While Cipla Ltd. guided to launch at least one specialty/limited competition drug in a quarter, its plan for first specialty product launch in U.S. received a setback post Food and Drug Administration’s second CRL (complete response letter) in IV Tramadol.
U.S. Food and Drug Administration issued second CRL on the new drug applicaiton of IV Tramadol, stated that
'delayed and unpredictable onset of analgesia' quashes the claim of effective treatment of patients in acute pain and
Insufficient data to support its claim to be effective in combination therapy.
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