`
`ANDA 65-004
`
`Bedford Laboratories
`Attention: Shahid Ahmed
`270 Northfield Road
`Bedford, OH 44146
`
`Dear Sir:
`
`This is in reference to your abbreviated new drug application
`dated December 19, 1997, submitted pursuant to Section 505(j)
`of the Federal Food, Drug, and Cosmetic Act, for Cyclosporine
`Injection USP, 50 mg/mL, packaged in 250 mg/5 mL single-use
`vials. We note that this product is subject to the exception
`provisions of Section 125(d)(2) of Title I of the Food and
`Drug Administration Modernization Act of 1997.
`
`Reference is also made to your amendments dated September 8,
`1998; and May 21, June 23, August 24, and October 6, 1999.
`
`We have completed the review of this abbreviated application
`and have concluded that the drug is safe and effective for use
`as recommended in the submitted labeling. Accordingly, the
`application is approved. The Division of Bioequivalence has
`determined your Cyclosporine Injection USP, 50 mg/mL, to be
`bioequivalent and, therefore, therapeutically equivalent to
`the listed drug (Sandimmune7 Injection, 50 mg/mL, of Novartis
`Pharmaceuticals Corp.).
`
`Under 21 CFR 314.70, certain changes in the conditions
`described in this abbreviated application require an approved
`supplemental application before the change may be made.
`
`Post-marketing reporting requirements for this abbreviated
`application are set forth in 21 CFR 314.80-81 and 314.98. The
`Office of Generic Drugs should be advised of any change in the
`marketing status of this drug.
`
`We request that you submit, in duplicate, any proposed
`advertising or promotional copy that you intend to use in your
`initial advertising or promotional campaigns. Please submit
`all proposed materials in draft or mock-up form, not final
`
`
`
`print. Submit both copies together with a copy of the
`proposed or final printed labeling to the Division of Drug
`Marketing, Advertising, and Communications (HFD-40). Please
`do not use Form FD-2253 (Transmittal of Advertisements and
`Promotional Labeling for Drugs for Human Use) for this initial
`submission.
`
`We call your attention to 21 CFR 314.81(b)(3) which requires
`that materials for any subsequent advertising or promotional
`campaign be submitted to our Division of Drug Marketing,
`Advertising, and Communications (HFD-40) with a completed Form
`FD-2253 at the time of their initial use.
`
`Sincerely yours,
`
`Douglas L. Sporn
`Director
`Office of Generic Drugs
`Center for Drug Evaluation and
`
`Research
`
`
`
`Page 3
`Page 3
`
`
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