Showing posts with label Estriol. Show all posts
Showing posts with label Estriol. Show all posts

Wednesday, August 14, 2013

It is a Myth That the FDA is Trying to Pull All Compounded Hormone Therapies off the Market; Estriol Can Be Used When Prescriber Has a Valid Investigational New Drug (IND) Application.


Myth: FDA wants all compounded hormone therapies off the market.
Fact: "We are not trying to pull all compounded hormone therapies off the market," says Silverman. "We believe that, like all traditionally compounded drugs, a woman should be able to get a compounded hormone therapy drug when her physician decides that it will best serve her specific medical needs. But we also want women to be informed and careful about choosing products that have not been proven safe and effective. And pharmacies cannot promote compounded drugs with false or misleading claims."
In addition, FDA has not approved any drug containing the hormone estriol. Pharmacies should not compound drugs containing estriol unless the prescriber has a valid investigational new drug (IND) application. INDs provide benefits that include allowing physicians to treat individual patients with drugs that are not FDA-approved, while also providing additional safeguards for patients.
quoted from here

Saturday, June 30, 2012

Code of Federal Regulation for Incurin (Estriol) tablet


Oral Dosage Form New Animal Drugs; Estriol

Action

Final Rule.

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of estriol tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.Show citation box

Table of Contents

DATES: Back to Top

This rule is effective December 16, 2011.

FOR FURTHER INFORMATION CONTACT: Back to Top

Lisa M. Troutman, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, (240) 276-8322, email: lisa.troutman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Back to Top

Intervet, Inc., 556 Morris Ave., Summit, NJ 07901, filed NADA 141-325 that provides for the veterinary prescription use of INCURIN (estriol) Tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs. The NADA is approved as of July 24, 2011, and the regulations are amended in 21 CFR part 520 to reflect the approval.
A summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The Agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.Show citation box
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning on the date of approval.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520 Back to Top

Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS Back to Top

1. The authority citation for 21 CFR part 520 continues to read as follows:

Authority: Back to Top

21 U.S.C. 360b.Show citation box
2. Add § 520.852 to read as follows:
§ 520.852 Estriol.
(a) Specifications. Each tablet contains 1 milligram (mg) estriol.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. Administer at an initial dose of 2 mg per dog per day. The dosage may be titrated to as low as 0.5 mg per dog every second day, depending on response.
(2) Indications for use. For the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Dated: December 9, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-32214 Filed 12-15-11; 8:45 am]

Wednesday, June 20, 2012

FDA's Questions and Answers to Compounded Menopausal Hormone Therapy for Humans

Compounded Menopausal Hormone Therapy Questions and Answers

     

Pharmacy Compounding 


1. What is pharmacy compounding?
FDA regards traditional pharmacy compounding as the combining or altering of ingredients by a pharmacist, in response to a licensed practitioner’s prescription, to produce a drug tailored to an individual patient’s special medical needs. In its simplest form, traditional compounding may involve reformulating a drug, for example, by removing a dye or preservative in response to a patient allergy. In the case of menopausal hormone therapy, an FDA approved progesterone product contains peanut oil. Progesterone compounded without peanut oil in response to a prescription for a specific patient who is allergic to this ingredient might allow the patient to safely use the drug.
2. Is combining two or more drugs considered compounding?
FDA would consider the combining of two or more FDA-approved drugs into a single medication, in a manner not described in a drug’s FDA-approved labeling, to be compounding if it is done by a pharmacist in response to a licensed practitioner’s prescription and produces a medication tailored to an individual patient’s special medical needs.
3.  Is pharmacy compounding beneficial for patients?
It can be.  Traditional pharmacy compounding enhances patient treatment with individually-tailored drugs when a physician deems that an FDA-approved drug may not be available or appropriate for that patient's care.  Thus, traditional compounding is an important component of patient care.