Lymol Medical Corp - 570153 - 01/08/2019

WARNING LETTER

Jan 8, 2019

VIA UNITED PARCEL SERVICE

Ref:#19-HFD-45-01-01

Lymol Medical Corporation

Attention: Kim Abrano, Chairman & CEO

4 Plympton Street

Woburn, MA 01801

Dear Ms. Abrano:

The U.S. Food and Drug Administration (FDA) has determined that Lymol Medical Corporation (“Lymol”) failed to comply with the milestone date in the timetable for completion of a postmarketing requirement (PMR) for Sterile Talc Powder® under New Drug Application (NDA) 21388. Failure to comply with PMR milestone dates without demonstrating good cause for noncompliance is a violation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 355(o)(3)] and renders Sterile Talc Powder® misbranded under section 502(z) [21 U.S.C. 352(z)] of the Act.

This violation is concerning from a public health perspective because FDA is aware of lead content in sterile talc, and failure to conduct the PMR impedes the evaluation of neurological, reproductive, developmental, immune, cardiovascular, and renal toxicities from lead exposure through use of Sterile Talc Powder®.

On February 5, 2018, FDA notified you of the requirement to complete the following PMR:

3332-1 Perform a risk assessment study on the lead content of sterile talc powder and indicate any necessary controls on elemental impurities as per ICH Q3D Elemental Impurities: Guidance for Industry.

TIMETABLE FOR COMPLETION

Final Report Submission: May 2018

Background

On February 5, 2018, FDA notified Lymol of its requirement to conduct PMR 3332-1.

On August 9, 2018, FDA notified Lymol, in a Missed PMR Milestone Letter, of its failure to comply with the Final Report Submission date. FDA provided 30 days for Lymol to submit an explanation for noncompliance with the PMR timetable for completion, and provided Lymol with the opportunity to propose a revised timetable for fulfilling the requirement.

On September 21, 2018, FDA determined Lymol failed to demonstrate good cause for its failure to comply with PMR 3332-1, based on Lymol’s failure to respond to the Missed PMR Milestone Letter.

On September 21, 2018, FDA issued a Failure to Respond Letter reminding Lymol of its failure to respond to FDA’s August 9, 2018 Notification of Missed PMR Milestone Letter. FDA provided 30 days for Lymol to submit the required submission containing the final report and referred this matter to the Office of Compliance.

Conclusion and Requested Action

As the NDA holder of Sterile Talc Powder®, your firm is subject to PMR 3332-1, including the milestone that constitutes its timetable for completion, until a formal request to withdraw your NDA has been submitted and withdrawal of the NDA is published in the Federal Register.

Your firm has failed to comply with the timetable for completion under section 505(o)(3)(E)(ii) of the Act and failed to demonstrate good cause for noncompliance with PMR 3332-1. Under section 502(z) of the Act, Sterile Talc Powder® is considered misbranded within the meaning of the Act. The required postmarketing study described above is considered to be in delayed status. The statuses of all postmarketing requirements are on the FDA Postmarketing Requirement and Commitments Web site at http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm.

Failure to promptly correct this violation may result in regulatory actions by FDA without further notice. These actions include, but are not limited to, civil money penalties. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within thirty (30) calendar days from the date of this letter, you should submit to your NDA the final study report for your PMR. Prominently identify your submission to your NDA with the following wording in bold, capital letters at the top of the first page, as follows:

PMR/PMC CORRESPONDENCE/GENERAL CORRESPONDENCE OSI/RESPONSE TO WARNING LETTER

Please send a hard copy of the cover letter from your written response to the following address:

Attention: Hee (Sheila) Lianos

Office of Scientific Investigations

Food and Drug Administration

Building 51, Room 5337

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

If you are considering an action that is likely to lead to a meaningful disruption in the supply of Sterile Talc Powder®, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.gov, so that FDA can work with you on bringing your operations into compliance with the law in a way that would help prevent or mitigate a drug shortage. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid a drug shortage and protect the health of patients who depend on your products.

If you have any questions regarding this letter, please call Hee Lianos, the PMR compliance officer for the Office of Scientific Investigations, at 301-796-4147.

Sincerely yours,

{See appended electronic signature page}

David Burrow, Pharm.D., J.D.

Director

Office of Scientific Investigations

Office of Compliance Center for Drug Evaluation and Research

Food and Drug Administration

Reference ID: 4373029

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This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.

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DAVID C BURROW

01/08/2019 04:11:14 PM