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APPENDIX TO CLINICAL PHARMACOLOGY REVIEW - accessdata fda

APPENDIX TO CLINICAL PHARMACOLOGY REVIEW - accessdata fda 2025

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The document provides a comprehensive review of the New Drug Application (NDA) for Azilsartan Medoxomil (TAK-491), an angiotensin II receptor blocker proposed for the treatment of hypertension. It includes clinical pharmacology and biopharmaceutics evaluations, detailing pharmacokinetic studies, dose-response relationships, and drug interactions. The findings indicate that Azilsartan exhibits a flat dose-response relationship with no significant benefit observed at higher doses compared to lower ones. The review recommends approval for the 40 mg strength based on its efficacy and safety profile, while also discussing the drug's metabolism, elimination pathways, and effects in specific populations such as those with renal or hepatic impairments.

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What is FDA license in India?

The FDA regulates products including biological products, medical services, cosmetics, prescription drugs and non-prescription drugs, veterinary drugs, tobacco and other radiation emitting products. FDA issues form 483 for FDA Certification of the products after the inspection by an official of FDA.

What is the full form of FDA in India?

Food and Drug Administration India Office.

What is the meaning of FDA in the Philippines?

As a regulatory agency under the Department of Health, the Food and Drug Administration, created under Republic Act No. 3720, series of 1963, as amended by Executive Order 175, series of 1987, otherwise known as the Food, Drugs and Devices, and Cosmetics Act, and subsequently Republic Act No.

What is FDA called in India?

The Central Drugs Standard Control Organisation(CDSCO)under Directorate General of Health Services,Ministry of Health Family Welfare,Government of India is the National Regulatory Authority (NRA) of India.

How long does it take for BLA approval?

Priority review (FDA) In the United States, the standard review time for an NDA or BLA is 12 months for an initial application and 10 months for a supplemental application (both timelines include a 60‐day filing review period).

Does FDA apply to India?

In India, the FDA usually is engaged in regulatory decisions regarding various products which are being exported to the US from India. It also performs various other activities that are mentioned as follows: Regular inspections of medical products and equipment that are exported to the US.

How long is the NDA review?

FDA Review Once FDA receives an NDA, the review team decides if it is complete. If it is not complete, the review team can refuse to file the NDA. If it is complete, the review team has 6 to 10 months to make a decision on whether to approve the drug.

What does FDA mean?

Food and Drug Administration Food and Drug Administration / Full name

APPENDIX TO CLINICAL PHARMACOLOGY REVIEW - accessdata fda 2025

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