Drug firm Cipla on Tuesday said its step-down associate firm Avenue Therapeutics Inc has received a second complete response letter (CRL) from the US health regulator for its new drug application for intravenous tramadol.
The CRL stated that the delayed and unpredictable onset of analgesia with intravenous tramadol does not support its benefit as a monotherapy to treat patients in acute pain, Cipla said in a regulatory filing.
The letter stated that there is insufficient information to support that intravenous tramadol in combination with other analgesics is safe and effective for the intended patient population.
"Avenue Therapeutics... a company focused on the development of intravenous tramadol for the US market... has received a second Complete Response Letter from the US Food and Drug Administration (USFDA) regarding its new drug application seeking approval for IV tramadol," Cipla said.
The USFDA did not identify any chemistry, manufacturing and controls issues in this CRL. Avenue disagrees with the USFDA''s interpretation of the data in the new drug application and intends to continue to pursue regulatory approval for IV tramadol, the filing added.
Cipla is a multinational firm headquartered in Mumbai. It has 46 state-of-the-art facilities including active pharmaceutical ingredients (API) and formulations, manufacturing over 1,500 products across diverse therapeutic categories.