The USFDA has granted Prior Approval Supplement (PAS) permission to Zydus Lifesciences Limited (previously Cadila Healthcare Ltd.) to commercialize Mycophenolate Mofetil Injection USP, 500 mg/vial (US RLD: CellCept injection). The injection will be produced in the company’s Gujarati injectables manufacturing facility in Jarod, close to Vadodara. The site transfer to the Jarod site was covered under the Prior Approval Supplement (PAS). The USFDA just performed an inspection of this location. Previously, in September 2017, the company received authorization to sell 500 mg/vial Mycophenolate Mofetil for Injection.
For patients getting renal, hepatic, or cardiac transplants, mycophenolate mofetil is suggested for use in combination with other medications, such as cyclosporine and corticosteroids, in order to prevent organ rejection. Since the filing procedure began in FY 2003–2004, the group has received 330 approvals and has submitted over 400 ANDAs.
More About Mycophenolate Mofetil
Mycophenolate mofetil (MMF) is a medication used to prevent organ rejection in patients who have received a kidney, heart, or liver transplant. It is an immunosuppressant drug that works by inhibiting the proliferation of T and B lymphocytes, which are involved in the immune response that can cause rejection of a transplanted organ.
MMF is typically administered orally in the form of capsules or tablets, and it is usually taken twice a day. It is metabolized in the liver to its active form, mycophenolic acid (MPA), which then works to suppress the immune response.
MMF has been shown to be effective in reducing the incidence of rejection in transplant patients, and it is often used in combination with other immunosuppressive drugs, such as corticosteroids and calcineurin inhibitors.
Like all medications, MMF can cause side effects, including gastrointestinal symptoms such as diarrhea, nausea, and vomiting, as well as headaches, dizziness, and infections. Patients taking MMF may also be at increased risk of developing certain types of cancer, such as lymphoma and skin cancer.
As with any medication, patients taking MMF should be closely monitored by their healthcare provider to ensure that the drug is being used safely and effectively.
More About Zydus Lifesciences Limited
Zydus Lifesciences Limited is a global pharmaceutical company headquartered in Ahmedabad, India. It is a subsidiary of Zydus Cadila, one of the leading pharmaceutical companies in India. Zydus Lifesciences Limited focuses on developing, manufacturing, and marketing a wide range of pharmaceutical products across several therapeutic areas, including cardiovascular, gastrointestinal, respiratory, pain management, and anti-infective medications. The company also has a strong presence in the field of biosimilars and biologics.
In addition to its operations in India, Zydus Lifesciences Limited has a significant global presence, with a strong presence in several international markets including the United States, Europe, Latin America, and Asia-Pacific. The company is committed to developing innovative and cost-effective medicines that meet the needs of patients around the world. It invests heavily in research and development, and has a robust pipeline of new products under development.
Zydus Lifesciences Limited is recognized for its high standards of quality, safety, and efficacy, and has received numerous awards and accolades for its contribution to the global pharmaceutical industry.
More About USFDA
The USFDA stands for the United States Food and Drug Administration. It is a federal agency of the United States Department of Health and Human Services that is responsible for regulating and supervising food safety, dietary supplements, prescription and over-the-counter medications, vaccines, medical devices, and other related products.
The FDA’s primary mission is to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation. The agency also conducts research to support its regulatory decisions and educates the public about health and safety issues related to FDA-regulated products.
The FDA plays a critical role in ensuring the safety and effectiveness of medical products, and its approval is required for new drugs, biologics, and medical devices to be sold in the United States. The agency also monitors and investigates potential safety concerns with these products and takes regulatory action when necessary to protect public health.
More About Prior Approval Supplement
A Prior Approval Supplement (PAS) is a type of regulatory submission to the USFDA made by a drug manufacturer seeking approval for a change to an existing approved drug product. PAS are required for changes that may affect the safety, efficacy, or quality of a drug, such as changes to the manufacturing process, formulation, or labeling.
The purpose of a PAS is to provide the FDA with the information necessary to evaluate the impact of the proposed changes on the drug product’s safety and effectiveness. The FDA will review the PAS and determine if the changes are acceptable, and if so, will issue an approval letter authorizing the changes.
Examples of changes that may require a PAS include adding a new indication for use, changing the manufacturing process, or adding a new dosage form. PAS are required to ensure that any changes to an approved drug product do not compromise its safety or efficacy and to ensure that the product continues to meet the FDA’s standards for quality and effectiveness.
PAS are an important aspect of the FDA’s regulatory oversight of drugs, as they help to ensure that any changes to an approved drug product are carefully evaluated and meet the agency’s standards for safety, efficacy, and quality.
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