Get the free Filgrastim License Supplement 96-1136 - fda
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This document outlines the summary, clinical background, regulatory status, safety, and efficacy of Filgrastim for the treatment of acute myeloid leukemia (AML). It includes details from clinical
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How to fill out filgrastim license supplement 96-1136
How to fill out Filgrastim License Supplement 96-1136
01
Step 1: Gather all necessary patient information, including name, date of birth, and medical history.
02
Step 2: Obtain dosage information based on the patient's chemotherapy regimen and current health status.
03
Step 3: Fill in the prescribing physician's details, including name, contact information, and signature.
04
Step 4: Provide the patient's insurance information to facilitate billing.
05
Step 5: Review the completed license supplement for accuracy and completeness.
06
Step 6: Submit the form to the appropriate regulatory agency or governing body as instructed.
Who needs Filgrastim License Supplement 96-1136?
01
Patients undergoing chemotherapy who require support for neutrophil production to reduce the risk of infection.
02
Healthcare providers and clinics that administer chemotherapy and need to comply with regulatory standards.
03
Pharmaceutical companies involved in the distribution and management of Filgrastim treatments.
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People Also Ask about
Is filgrastim covered by Medicare?
In 2018, the average cost per claim in Medicare Part B for filgrastim-sndz and tbo-filgrastim was 68.8% and 64.9% of filgrastim, respectively. The average cost per claim in Medicare Part D for filgrastim-sndz and tbo-filgrastim was 83.2% and 89.7% of filgrastim, respectively.
How much does filgrastim cost in the US?
ing to the manufacturer of the biosimilar, the US wholesale price of filgrastim-sndz for 300-mcg dosing is $275.66, and $438.98 for the 480-mcg formulation.
What is the cost of filgrastim 300 mcg injection?
Filgrastim 300 Mcg, Intas Pharmaceuticals, Packaging Size: 1 Pfs at ₹ 1706.58/piece in Mumbai.
How much does Neupogen cost in the US?
The cost for Neupogen (300 mcg/0.5 mL) injectable solution is around $366 for a supply of 0.5 milliliters, depending on the pharmacy you visit.
How often do you need to get filgrastim injections?
It is usually given once a day, but filgrastim injection products (Neupogen, Nivestym, Releuko, Zarxio) may be given twice a day when it is used to treat severe chronic neutropenia. The length of your treatment depends on the condition that you have and how well your body responds to the medication.
What is the drug filgrastim used for?
Filgrastim injection is used to treat neutropenia (low white blood cells) that is caused by cancer medicines. It is a synthetic (man-made) form of a substance that is naturally produced in your body called a colony stimulating factor. Filgrastim helps the bone marrow to make new white blood cells.
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What is Filgrastim License Supplement 96-1136?
Filgrastim License Supplement 96-1136 is a regulatory submission to the FDA for the approval of the biologic drug Filgrastim, which is used to stimulate the production of white blood cells in patients with certain conditions.
Who is required to file Filgrastim License Supplement 96-1136?
The manufacturer or sponsor of the drug Filgrastim is required to file License Supplement 96-1136 to seek approval for changes in the drug's formulation, manufacturing process, or labeling.
How to fill out Filgrastim License Supplement 96-1136?
To fill out Filgrastim License Supplement 96-1136, the applicant must provide detailed information regarding the drug's chemistry, manufacturing practices, clinical data, and any additional information required by the FDA forms.
What is the purpose of Filgrastim License Supplement 96-1136?
The purpose of Filgrastim License Supplement 96-1136 is to obtain FDA approval for modifications related to the drug's production, safety, efficacy, or labeling, ensuring that it continues to meet regulatory standards.
What information must be reported on Filgrastim License Supplement 96-1136?
The information that must be reported includes data on clinical studies, manufacturing processes, quality control measures, labeling changes, and any adverse events associated with Filgrastim.
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