[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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have withdrawn the hearing requests.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