Acacia gets 2nd FDA rejection as manufacturing fault drags on

fiercebiotech | April 03, 2019

Acacia gets 2nd FDA rejection as manufacturing fault drags on
Acacia Pharma has suffered its second FDA rejection in seven months. The British drug developer moved quickly to bounce back from the complete response letter (CRL) it received in October, only to be hit with a second rejection after its contract manufacturer failed to resolve the problems.
After disclosing the first CRL for post-operative nausea and vomiting drug Barhemsys last year, Acacia continued to prepare to introduce the drug in the first half of 2019 in the belief the problems behind the rejection would be quick to resolve. Acacia told investors the issue was limited to one regulatory compliance deficiency at the third party that produces the active ingredient in Barhemsys, and that the FDA had no qualms with the quality of the drug or the R&D data included in the submission. Within one month of the CRL, the contract manufacturer submitted a plan to fix the problem and Acacia refiled for FDA approval of Barhemsys. Shares in Acacia rose sharply in March and April in anticipation of the May 5 PDUFA decision.

Spotlight

Kaifeng Red Maple Leaf Biotechnology Co., Ltd. was founded in 2004. Our company is located in Kaifeng, Henan, China, covering an area of 26 thousand square meters with 287 employees. Being in the leading position in the industry, we have 5 modern advanced production lines, including 3 production lines of soft capsules and 2 production lines of tablets.

Spotlight

Kaifeng Red Maple Leaf Biotechnology Co., Ltd. was founded in 2004. Our company is located in Kaifeng, Henan, China, covering an area of 26 thousand square meters with 287 employees. Being in the leading position in the industry, we have 5 modern advanced production lines, including 3 production lines of soft capsules and 2 production lines of tablets.

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