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 Product Approval Information - Licensing Action

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

December 16, 1997

Our Reference No. 96-1408

Ms. Joan F. Roelands
OMJ Pharmaceuticals, Inc.
Carr. #2, Km 45.6
Bo. Campo Alegre
Manati, Puerto Rico 00674

Dear Ms. Roelands:

Your biologics license application for Becaplermin is approved effective this date. OMJ Pharmaceuticals, Inc., Manati, Puerto Rico, is hereby authorized to manufacture and ship for sale, barter, or exchange in interstate and foreign commerce Becaplermin under Department of Health and Human Services Biologics License No. 1196.

Becaplermin is indicated for treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond, and have adequate blood supply.

Under this authorization, you are approved to manufacture Becaplermin utilizing Becaplermin Concentrate manufactured by Chiron Corporation (Biologics License No. 1106) under a shared manufacturing arrangement. Any addition or deletion of establishments involved in the shared manufacturing arrangement will require the submission of appropriate supporting data in order to ensure continued compliance with the approved standards for the manufacture of Becaplermin.

In accordance with approved labeling, your product will be distributed by McNeil Pharmaceutical under the tradename Regranex, and will be marketed as a gel formulation in 2, 7.5 and 15 gram fill sizes.

You are not currently required to submit samples of future lots of this product to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2. FDA will continue to monitor compliance with 21 CFR 610.1 requiring assay and release of only those lots that meet release specifications.

The dating period for this product shall be 9 months from the date of manufacture when stored at 2-8°C. The date of manufacture shall be defmed as the date of formulation of the final gel product. Results of ongoing stability studies should be submitted throughout the dating period as they become available including the results of stability studies from the first three production lots.

We acknowledge your written commitments dated December 15, 1997 to:

  1. Identify (im conjunction with RWJPRI) with due diligence the cause for the change in the stability profile observed with the finished drug product. After sufficient data are collected and analyzed, submit the conclusions of the investigation to the Agency.
  2. Place ________ batches of Becaplermin on stability program at 5°C (2-8°C). Place at least one production batch per tube size on stability each month that particular tube size is manufactured from November, 1997 to September, 1998. If the 2, 7.5 and 15g tube sizes are all manufactured within the same month, then only the 2 and 15g tube sizes will be placed on stability to bracket the results.
  3. Continuously monitor the temperature of product shipments from OMJ Pharmaceuticals, Inc., _____ Puerto Rico, to the _______ Distribution Center, ____________ _________ Real time, freeze/thaw, and accelerated temperature stability data will be collected from 3 lots of product to document the long term stability following temperature excursions. Until additional stability data are gathered, samples from any lot exposed to temperatures outside 2-8°C will not be commercially distributed without agency concurrence and if released, samples will be placed on a stability study.
  4. Validate shipping of stability samples sent to Chiron Corporation and to discard any samples exposed to temperatures outside of the specified range.
  5. Manufacture a ____ lot of product for which the thawed drug substance was held for 18 days. This lot will be entered into the stability program.
  6. We also acknowledge additional information in your letter of December 15, 1997, addressing the agency’s observations noted during the April 28 - May 7, 1997, preapproval inspection and your commitment to provide further information and data within the timelines specified.
  7. In addition; we acknowledge your letter of December 11, 1997 in which you commit to submitting to CBER final reports of the clinical studies for Becaplermin in venous stasis and pressure ulcers.

Any changes in the supplier of Becaplermin Concentrate, or in the manufacture, packaging or labeling of the product or in the manufacturing facilities will require the submission of information to your biologics license application for our review and written approval consistent with 21 CFR 601.12.

It is requested that adverse experience reports be submitted in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) and that distribution reports be submitted as described (21 CFR 600.81). All adverse experience reports should be prominently identified according to 21 CFR 600.80 and be submitted to the Center for Biologics Evaluation and Research, HFM-210, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.

Please submit three copies of all final printed labeling at the time of use and include part II of the label transmittal form with completed implementation information. In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2567 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Staff, HFM-202, 1401 Rockville Pike, Rockville, MD 20852-1448. Final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by an FDA Form 2567. All promotional claims must be consistent with and not contrary to approved labeling. No comparative promotional claim or claim of superiority over other similar products should be made unless data to support such claims are submitted to and approved by the Center for Biologics Evaluation and Research.

Sincerely yours,
--- signature ---

Jay P. Seigel, M.D., FACP
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research

Last Updated: 1/18/2001

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Date created: September 25, 2003

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