DEPARTMENT OF HEALTH & HUMAN SERVIC'ES

Food and Drug Administration

R2ckvi!ic MD 2CC57

Fmring, Inc.

Attention: W. Richard Jeysman

200 Yorkland Blvd., Suite 800

North York, Ontario

CANADA M2J 5Cl

: * Docket No. OOP-1213KPl

Dear Mr. Jeysman:

This is in response to your petition filed on March 14,2000, requesting permission to file an

Abbreviated New Drug Application (ANDA) for the following drug product: Calcitonin Salmon

Injection 100 IU/mL, 1mL vials. The listed drug product to which you refer in your petition is

MiacalcinB (Calcitonin Salmon) Injection, 200 IU/mL, 2mL vials, manufactured by Novartis

Pharmaceuticals, Corp.

Your request involves a change in strength (a change in the concentration, and a change in the

total drug content) from that of the listed drug product (i.e., 200 IU/mL, 2mL (total drug content

400 JU) to 100 IU/mL, 1 mL (total drug content 100 IU)). The change you request is the type of

change that is authorized under the Act.

.

.

We have reviewed your petition under Section 505(j)(2)(C) of the Federal Food, Drug, and

Cosmetic Act (Act) and have determined that it is approved. This letter represents the Agency's

determination that an ANDA may be submitted for the above-referenced drug product.

Under Section 505(j)(2)(C)(i) of the Act, the Agency must approve a petition seeking a change in

strength which differs from the strength of the listed drug product unless it finds that

investigations must be conducted to show the safety and effectiveness of the differing strength.

The Agency finds that the change in strength (concentration and total drug content) for the

specific proposed drug product does not pose questions of safety or effectiveness because the

uses, dose, and route of administration of the proposed drug product are the same as that of the

listed drug product. The Agency concludes, therefore, that investigations are not necessary in

this instance. In addition, if shown to meet bioavailability requirements, the proposed drug

product can be expected to have the same therapeutic effect as the listed reference drug product.

The approval of this petition to allow an ANDA to be submitted for the above-referenced drug

product does not mean that the Agency has determined that an ANDA will be approved for the

drug product. The determination of whether an ANDA will be approved is not made until the

ANDA itself is submitted and reviewed by the Agency..For your information, the listed drug product to which you refer is covered by a period of patent

protection which appears in the Auoroved Drug Products With Therapeutic Eauivalence

Evaluations 20th Edition, published by the Agency. The existence of such patents will require a

certificatioi upon submission of an ANDA for your proposed drug product and may also affect

the approval date of any ANDA.

To permit review of your ANDA submission, you must submit all information required under

Sections 505(j)(2)(A) and (B) of the Act. To be approved, the drug product will, among other

things be required to meet current bioavailability requirements under Section 505@(2)(A)(iv) of

the Alt. We suggest that you submit your protocol to the Office of Generic Drugs, Division of

Bioequivalence for this drug product prior to the submission of your ANDA. During the review

of your application, the Agency may require the submission of additional information.

The listed drug product to which you refer in your ANDA must be the one upon which you based

this petition. In addition, you should refer in your ANDA to the appropriate petition docket

number cited above, and include a copy of this letter in the ANDA submission.

Please be advised that formulations of drug products or inactive ingredient changes are not

evaluated during the review and approval of the petition. Any changes in formulation or inactive

ingredients are evaluated during the review of the ANDA.

A copy of this letter approving your petition will be placed on public display in the Dockets

Management Branch, Room 1061, Mail Stop HFA-305,563O Fishers Lane, Rockville, MD

20852.

Sincerely yours,

Acting Director

Office of Generic Drugs

Center for Drug Evaluation and Research -