Amneal Pharmaceuticals received a Complete Response Letter (CRL) from the FDA regarding the Company’s New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease. The letter indicated that although an adequate scientific bridge was established for the safety of one ingredient, levodopa (LD), based on pharmacokinetic studies, it was not adequately established for the other ingredient, carbidopa (CD), and FDA has requested additional information. The letter did not identify any issues with respect to the efficacy or manufacturing of IPX203. Amneal will work closely with the FDA to address its comments and plans to meet with the agency to align on the best path forward.
The FDA published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). The OPOE list includes approved new drug applications (NDAs) for drug products that are not protected by patents or exclusivities at the time of each update, and for which FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA. The FDA maintains the OPOE list to improve transparency and encourage the development and submission of applications under an abbreviated approval pathway for drugs with limited competition. The FDA updates this list every six months to ensure continued transparency regarding drug products where increased competition has the potential to provide significant benefit to patients.
Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish CDMO, expects to double their lyophilization capacity for their fully automated, isolator-based filling line to meet new demand. A second lyophilizer will be added to the line to increase capacity to 70,000 10R vials per run. The company’s current lyophilization capacity on the line is 35,000 10R vials and the addition of the redundant lyophilizer will double that capacity to 70,000 10R vials. The company expects to lyophilize GMP lots on the new lyophilizer by Q4 of 2025.
Bausch + Lomb entered into a definitive agreement with Novartis under which the company will acquire XIIDRA® a non-steroid eye drop specifically approved to treat the signs and symptoms of dry eye disease focusing on inflammation associated with dry eye. As part of the transaction, Bausch + Lomb will also acquire libvatrep, an investigational compound being studied for the treatment of chronic ocular surface pain, and AcuStream™ technology, an investigational device that may have the potential to facilitate precise dosing and accurate delivery of certain topical ophthalmic medications to the eye. Libvatrep is currently in Phase 2b development with study results expected in the third quarter of 2023.
Orexo announced that the US District Court for the District of New Jersey ruled in favor of the company in its patent litigation against Sun Pharma regarding ZUBSOLV® sublingual tablets in the US. The district court found that Orexo´s patents are valid and infringed by Sun. The court's decision concludes the litigation that was initiated in September 2020 as a response to Sun's submission of an Abbreviated New Drug Application with the FDA seeking approval of generic versions of ZUBSOLV®. As a result of the decision, Sun is prohibited from launching its generic ZUBSOLV® tablets until September 2032, and Orexo's patent protection remain unchanged.