Vaccines, Blood & Biologics

August 4, 2011 Approval Letter - Anascorp

Our STN: BL 125335/0

Rare Disease Therapeutics, Inc.
Attention: Mr. Milton H. Ellis
2550 Meridian Blvd., Suite 150
Franklin, TN 37067

Dear Mr. Ellis:

We are issuing Department of Health and Human Services U.S. License No. 1860 to Rare Disease Therapeutics, Inc., Franklin, Tennessee, under the provisions of section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.

Under this license, you are authorized to manufacture the product Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection. Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection is indicated for the treatment of clinical signs of scorpion envenomation.

The review of this product was associated with National Clinical Trial (NCT) numbers: 00696683 and 00685230.

Under this license, you are approved to manufacture Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection at Instituto Bioclon, S.A. de C.V in Tlalpan, Mexico D.F., Mexico. You may label your product with the proprietary name Anascorp® and will market it as 10 mL vials, each containing no more than 120 mg of protein and not less than 150 LD50 mouse neutralizing units.

We did not refer your application to the Blood Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.

The dating period for Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection shall be 24 months from the date of manufacture when stored at room temperature [up to 25 ºC (77 ºF)] with brief temperature excursions permitted up to 40 ºC (104 °F). The date of manufacture shall be defined as the date of filling. Following the final sterile filtration, no reprocessing/reworking is allowed without prior approval from the Agency.

Please submit final container samples of the product in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologic Evaluation and Research (CBER).

You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing, packaging or labeling of Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection, or in the manufacturing facilities.

You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.

Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. In addition, please submit three original paper copies for carton and container final printed labeling. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.

In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at Information on submitting SPL files using eLIST may be found in the guidance for industry titled, "SPL Standard for Content of Labeling Technical Qs and As at

You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).

All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).

You must submit adverse experience reports in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) and you must submit distribution reports as described in 21 CFR 600.81. You should submit postmarketing adverse experience reports and distribution reports to the Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology HFM-210, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Prominently identify all adverse experience reports as described in 21 CFR 600.80. Per 21 CFR 600.2(f), please refer to for updated mailing address information.

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable. Because the biological product for this indication has an orphan drug designation, you are exempt from this requirement.


We acknowledge your written commitments as described in your letters of July 12, 2011 and August 2, 2011, as outlined below:

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70

  1. -----------------------------------------------(b)(4)------------------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ---------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------
  2. -----------------------------------------------(b)(4)--------------------------------------------- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ------------------------------------------------------------------------------------------------ --------------------------------------------------------------------------------------------------- -----------------------------------------------------------------------------------------------------------------------------------------------------------
  3. -----------------------------------------------(b)(4)------------------------------------------- -------------------------------------------------------------------------------------------------- ------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  4. -----------------------------------------------(b)(4)----------------------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ---------------------------------------------------------------------------------------------- ------------
  5. -----------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------- ---------------------------------------------------------
  6. -----------------------------------------------(b)(4)---------------------------------------- ---------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------------- ----------------

Please submit the information for postmarking commitments 5 and 6, only, to the following address:

John A. Eltermann, Jr., R.Ph., M.S.
Division of Manufacturing and Product Quality
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Food and Drug Administration
Suite 200N, HFM-670
1401 Rockville Pike
Rockville, MD

We request that you submit information concerning nonclinical and chemistry, manufacturing, and control postmarketing commitments and final reports to your BLA, STN BL 125335/0.

For each postmarketing commitment not subject to the reporting requirements of 21 CFR 610.70, you may report the status to FDA as a "PMC Submission – Status Update." The status report for each commitment should include:

  • The original schedule for the commitment, and
  • The status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted).

When you have fulfilled your commitment, submit your final report as PMC Submission – Final Study Report or Supplement Contains Postmarketing Study Commitment – Final Study Report. Please indicate in the cover letter that the submission fulfills your commitments as stated in the approval letter for STN BL 125335/0.

It is recommended that a copy of this letter, identifying the commitments, be included in the submission.

Sincerely yours,


Mary A. Malarkey
Office of Compliance and
Biologics Quality
Center for Biologics
Evaluation and Research



Jay S. Epstein, M.D.
Office of Blood Research and
Center for Biologics
Evaluation and Research

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