FDA recommendations on Quality Considerations for Topical Ophthalmic Drug Products
The FDA guidance discusses on quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. The guidance specifically discusses on: Approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products. Use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage...
Stability data Requirements for a Marketing Authorization Application
Any drug substance or drug product has to maintain the same quality, safety and efficacy throughout the lifecycle of a product. Generally, the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. As we understood the quality of substance or product is varying in the presence of temperature and humidity over the period of time, any sponsor/applicant needs to provide supporting data and...
Residual Solvents – Basics, Classification and Assessment
Solvent – A substance, majorly liquid capable of dissolving or diluting other substances to form a solution. Generally, several solvents are used in the manufacturing of drug substance, excipients and drug products as a routine practice. The solvents are used to enhance the solubility, yield and to determine several critical factors needed for the final product, considered as a critical element in the manufacturing process. The solvents are organic and volatile in nature that are...
Impurities – Classification, Thresholds Limits, Specification with RTR Considerations in APIs and Finished Products
Every product should have a sufficient level of quality to ensure its efficacy and safety. The impurities/degradation products are the ones that arise during different stages of synthesis, manufacture and storage. They should be controlled at certain level to maintain the required quality of the drug substance/product. The potential impurities are most likely to arise during the synthesis of drug substance, purification, manufacturing and storage of the drug substance/drug product. The...
FDA Novel Drug Approvals in January 2022
QUVIVIQ ITEMDESCRIPTIONSPONSOR/HOLDERIDORSIA PHARMACEUTICALS LTDApplication No.#214985Application TypeNDAActive IngredientDaridorexantDosage FormTABLETRoute of AdministrationORALStrengthsEQ 25mg BaseIndication for UseTreatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenanceApproval Date07/01/2022 CIBINQO ITEMDESCRIPTIONSPONSOR/HOLDERPFIZER INCApplication No.#213871Application TypeNDAActive IngredientAbrocitinibDosage FormTABLETRoute of...