Fliban (Flibanserin) is a medication primarily used to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. It works by affecting certain neurotransmitters in the brain, specifically serotonin and dopamine, which are involved in regulating sexual desire.
Regarding regulatory compliance, Fliban's approval and regulation vary depending on the country or region. Here are some general considerations:
FDA Approval: In the United States, Flibanserin (brand name Addyi) was approved by the Food and Drug Administration (FDA) in 2015 for the treatment of acquired, generalized HSDD in premenopausal women. Its approval was based on clinical trials demonstrating its efficacy and safety profile.
Regulatory Requirements: Regulatory agencies such as the FDA require pharmaceutical companies to conduct rigorous clinical trials to demonstrate the safety and efficacy of medications before they can be approved for use. This process involves submitting comprehensive data on the medication's pharmacology, clinical studies, adverse effects, and manufacturing processes.
Labeling and Risk Evaluation: Due to safety concerns, particularly regarding potential interactions with alcohol and risk of hypotension and fainting, Flibanserin is subject to strict labeling requirements and risk evaluation and mitigation strategies (REMS). These measures aim to educate prescribers and patients about the risks associated with the medication and ensure its safe use.
Post-Marketing Surveillance: After approval, regulatory agencies continue to monitor the safety and effectiveness of medications through post-marketing surveillance programs. This involves collecting and analyzing reports of adverse events and taking appropriate regulatory actions if safety concerns arise.
Compliance with Regulations: Pharmaceutical companies manufacturing and distributing Flibanserin must comply with Good Manufacturing Practices (GMP) and other regulatory requirements to ensure the quality, safety, and consistency of the medication. This includes maintaining proper manufacturing facilities, conducting quality control testing, and adhering to labeling and packaging regulations.
Overall, Fliban 100 mg (Flibanserin) regulatory compliance involves meeting the stringent requirements set by regulatory agencies to ensure the medication's safety, efficacy, and quality. Compliance with these regulations is essential to obtain approval for marketing and distribution and to maintain the medication's regulatory status.  |
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