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Regulatory Focus™ > News Articles > 2019 > 11 > FDA Seeks to Pull 4 NDAs After Companies Failed to Submit Annual Reports

FDA Seeks to Pull 4 NDAs After Companies Failed to Submit Annual Reports

Posted 15 November 2019 | By Zachary Brennan 

FDA Seeks to Pull 4 NDAs After Companies Failed to Submit Annual Reports

After failing to file required annual reports related to four new drug applications (NDAs), the US Food and Drug Administration (FDA) on Friday proposed to withdraw approval of the NDAs, although the NDA holders can request hearings.

The annual reports are meant to provide FDA with further information on the drug from the previous year that might affect its safety, effectiveness or labeling. The reports are also required to contain a brief description of actions the applicant has taken or intends to take as a result of new information, such as for example, submitting a labeling supplement, adding a warning to the labeling or initiating a new study. 

In addition to failing to submit the annual reports, FDA also said the companies did not respond to the agency’s request for submission of the reports.

The NDAs in question are Pan American Laboratories’ Maolate (chlorphenesin carbamate) Tablet, 400 milligrams; Chart Medical’s Chymodiactin (chymopapain) for Injection, 4,000 Units/vial and 10,000 Units/vial; Iomed’s Iontocaine (epinephrine and lidocaine hydrochloride (HCl)) Topical Solution, 0.01 mg/milliliter; 2%; and Vyteris’s Lidosite topical system: LidoSite Patch (lidocaine HCl and epinephrine topical iontophoretic patch) 10%/0.1% and LidoSite Controller.

The action is the result of the director of FDA’s Center for Drug Evaluation and Research’s proposal to issue an order under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)), withdrawing approval of the applications “on the grounds that the NDA holders have failed to submit reports required under § 314.81.”

Fentanyl ANDAs Withdrawn

In addition to the NDAs, FDA on Friday also recommended the withdrawal of two abbreviated new drug applications (ANDAs) for generic versions of fentanyl transdermal systems with a liquid reservoir from Mayne Pharma Group and Teva Pharmaceuticals.

FDA said both generic drugs were indicated for “use in the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

Th agency also highlighted problems with the design of the system, noting: “FDA became aware of new information related to problems with the manufacturing, design, and quality control of fentanyl transdermal systems with a liquid reservoir design, leading to potential leakage, unintended opioid exposure, and potentially life-threatening adverse events.”

In June, Mayne requested withdrawal of the ANDA and waived its opportunity for a hearing. Teva subsidiary Actavis said that it voluntarily discontinued manufacture and sale of the fentanyl product in 2018 for commercial reasons.

Federal Register for NDAs

Federal Register for ANDAs

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