[Federal Register: April 14, 2005 (Volume 70, Number 71)]
[Notices]               
[Page 19762-19763]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap05-48]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1979N-0113 (formerly Docket No. 79N-0113); DESI 2847]

 
Drugs for Human Use; Drug Efficacy Study Implementation; 
Parenteral Multivitamin Drug Products; Announcement of Unlawful 
Formulations

AGENCY: Food and Drug Administration.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is declaring unlawful 
the unapproved marketing of certain parenteral multivitamin drug 
products for which a hearing was requested, but for which the sponsors 
have withdrawn the hearing requests. FDA is taking this action because 
the products lack substantial evidence of effectiveness as fixed 
combination drug products.

[[Page 19763]]


DATES: This notice is effective May 16, 2005.

ADDRESSES: Requests for an opinion of the applicability of this notice 
to a specific product should be identified with Docket No. 1979N-0113 
and reference number DESI 2847 and directed to the Division of New 
Drugs and Labeling Compliance (HFD-310), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug 
Research and Evaluation (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of September 17, 1984 (49 FR 36446) (the September 1984 
notice), FDA announced the conditions for marketing an effective 
parenteral multivitamin drug product. The effective 12-vitamin 
formulation set forth in the notice was based on the clinical 
evaluation of a guideline formulation recommended by the American 
Medical Association. (In the Federal Register of April 20, 2000 (65 FR 
21200), FDA amended the September 1984 notice by increasing the dosage 
of certain vitamins and by adding vitamin K to the formulation.) The 
September 1984 notice, published as part of the Drug Efficacy Study 
Implementation, also revoked the temporary exemption (paragraph XIV, 
category XI) for three original formulation products that had been 
allowed to remain on the market while guideline formulations were 
studied. The notice stated that FDA was unaware of any adequate and 
well-controlled clinical trials meeting the requirements of section 
505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
355(e)), 21 CFR 300.50, and 21 CFR 314.111(a)(5) (now 21 CFR 
314.125(b)(5)) and demonstrating the effectiveness of these products; 
therefore, FDA proposed to withdraw approval of the portions of the new 
drug applications (NDAs) pertaining to the original formulations. The 
notice offered affected parties an opportunity for a hearing on the 
proposal.
    In response to the September 1984 notice, Hoffmann-LaRoche, Inc., 
USV Pharmaceutical Corp., LyphoMed, Inc. (subsequently acquired by 
American Pharmaceutical Partners, Inc.), and Carter-Glogau 
Laboratories, Inc. (subsequently acquired by Schein Pharmaceutical, 
Inc.), submitted hearing requests. Hoffmann-LaRoche and USV voluntarily 
withdrew their hearing requests shortly after they were submitted; 
therefore, FDA withdrew approval of the NDAs for the Hoffmann-LaRoche 
and USV products in Federal Register notices of February 28, 1985 (50 
FR 8193), and December 27, 1985 (50 FR 53014). The following hearing 
requests were still pending:
    1. MultiVitamin Concentrate; No NDA; American Pharmaceutical 
Partners, Inc. (APP), 2045 North Cornell Ave., Melrose Park, IL 60160-
1002. Each 5-milliliter vial of MultiVitamin Concentrate contained 
ascorbic acid (vitamin C) 500 milligrams (mg), vitamin A (retinol) 3 mg 
(10,000 International Units (I.U.)), vitamin D (ergocalciferol) 25 
micrograms (1,000 I.U.), thiamine (B1) 50 mg, riboflavin (B2) 10 mg, 
pyridoxine (B6) 15 mg, niacin (B3) 100 mg, pantothenic acid 25 mg, and 
vitamin E 3 mg (5 I.U.).
    2. The hearing request, which named no specific product, referenced 
products named in the September 1984 notice; No NDA; Schein 
Pharmaceutical, Inc. (Schein), 100 Campus Dr., Florham Park, NJ 07932.
    In letters dated May 27, 1999, and April 8, 2003, Schein and APP, 
respectively, withdrew the hearing requests previously submitted 
regarding parenteral multivitamin products. The letter from APP noted 
that it had discontinued marketing MultiVitamin Concentrate. 
Accordingly, there are no pending hearing requests submitted in 
response to the September 1984 notice of opportunity for hearing. No 
parenteral multivitamin product remains exempt under the paragraph XIV, 
category XI exemption.
    This notice applies to any drug product that is identical, related, 
or similar to the products specified and referenced previously in this 
document and is not the subject of an approved NDA (21 CFR 310.6). Any 
person who wishes to determine whether a specific product is covered by 
this notice should write to the Division of New Drugs and Labeling 
Compliance (see ADDRESSES).
    Based on the information presented in the September 1984 and April 
20, 2000, Federal Register notices, the Acting Director of the Center 
for Drug Evaluation and Research, under the act (section 505(e)) and 
under authority delegated to him (21 CFR 5.100), finds that, on the 
basis of new information on these drugs, evaluated with the evidence 
available previously, there is a lack of substantial evidence that the 
products named and referenced previously will have the effects they are 
purported or represented to have under the conditions of use 
prescribed, recommended, or suggested in their labeling.
    Therefore, based on the foregoing finding, MultiVitamin Concentrate 
and the original formulation parenteral multivitamin product(s), for 
which Schein requested a hearing, are declared unlawful, effective May 
16, 2005.
    Shipment in interstate commerce of these drug products or any 
identical, related, or similar product that is not the subject of an 
approved NDA will then be unlawful.

    Dated: April 5, 2005.
Steven Galson,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 05-7532 Filed 4-13-05; 8:45 am]

BILLING CODE 4160-01-S