South Korea's Mezzion, a drug company is seeking damages from Dr Reddy's in a New Jersey court for committing fraud by hiding significant deficiencies and misrepresenting compliance in its manufacturing practices, the company said in a press release.
The suit states that Dr Reddy's repeatedly represented to Mezzion that it was compliant with FDA regulations, and that it hid its misconduct from Mezzion.
The suit also states that Dr. Reddy's misconduct was the sole reason given by the FDA to deny approval of Mezzion's new drug application (NDA) for udenafil for the treatment of erectile dysfunction (ED) and for FDA's refusal to grant marketing approval of Mezzion's udenafil finished drug product.
"As a result, Mezzion has incurred delay and expense and was forced to seek new manufacturers and suppliers for udenafil and the udenafil finished product, and Mezzion is currently taking the necessary steps required to resubmit its udenafil NDA to the FDA for approval", the press release said. Mezzion is seeking to recover "millions of dollars" in damages for fraud, fraudulent concealment and other counts.
The suit states that Dr Reddy's repeatedly represented to Mezzion that it was compliant with FDA regulations, and that it hid its misconduct from Mezzion.
The suit also states that Dr. Reddy's misconduct was the sole reason given by the FDA to deny approval of Mezzion's new drug application (NDA) for udenafil for the treatment of erectile dysfunction (ED) and for FDA's refusal to grant marketing approval of Mezzion's udenafil finished drug product.
"As a result, Mezzion has incurred delay and expense and was forced to seek new manufacturers and suppliers for udenafil and the udenafil finished product, and Mezzion is currently taking the necessary steps required to resubmit its udenafil NDA to the FDA for approval", the press release said. Mezzion is seeking to recover "millions of dollars" in damages for fraud, fraudulent concealment and other counts.
The suit dates back to the warning letter that Dr Reddy's received for its manufacturing facility at Srikakulam in 2015, these plants are currently under remediation, and USFDA is expected to re inspect it in February.