API and IP Newsletter
Contents FDA approvals in October 2024: 505 (b) (2). General information Commission fines Teva €462.6 million over misuse of the patent system FDA Approves Minocycline Hydrochloride Extended-Release Capsules for Individuals with Rosacea Intellectual Property Unilever Vs Henkel AG FDA approvals in October 2024: 505 (b) (2). We follow 505(b)(2) approvals on the FDA website. The 505(b)(2) pathway enables investigators and/or manufacturers to apply for approval without repeating all the drug development work done for an innovative drug. A 505(b)(2) applicant may rely on the FDA’s findings of safety and/or effectiveness for a listed drug only to the extent that the proposed product in the 505(b)(2) application shares characteristics (e.g., active ingredient, dosage form, route of administration, strength, indication, or other conditions of use) in common with the relied-upon listed drug/drugs. In 2019, the FDA published guidelines for the industry on whether an applicant sh
