Tag Archive for: manufacturing issues

Zealand Pharma said on Saturday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug for preventing and treating low blood sugar in children with a genetic disorder after finding deficiencies at a third-party manufacturing facility.

The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.

The FDA has rejected Eli Lilly’s investigational antibody lebrikizumab for the treatment of moderate-to-severe atopic dermatitis due to manufacturing problems, the company announced on Monday.

The company and a former employee agreed to settle a lawsuit in which the worker claimed she was terminated after pointing out poor manufacturing practices and data falsification involving one of its blockbuster diabetes drugs, according to court filings.

The U.S. Food and Drug Administration said on Wednesday there was a shortage of Adderall, a treatment for attention deficit hyperactivity disorder, following intermittent manufacturing delays at Teva Pharmaceutical Industries Ltd.

U.S. drug inspectors recently recorded several new quality- control problems at an Eli Lilly and Co plant that is already the subject of a federal investigation over manufacturing lapses, according to a government report reviewed by Reuters.