Sidvim LifeSciences Private Limited

  Contents Analysis of 505 (b) (2)s approved in the year 2018 General information FDA grants fast track status to Rznomics’ RZ-001 for HCC Sandoz to pay $275 million to settle drug price-fixing case Intellectual Property T 0295/22 (Orally administered apremilast/AMGEN)   Analysis of 505 (b) (2)s approved in the year 2018   From time to time, we analyse the 505 (b) (2) applications approved each year. Recently, we analysed the applications approved in 2018. The details of our analysis are provided below. In 2018, there were around seventy-eight NDA (505 (b)(2)) approvals. Additionally, six tentative approvals (TA). They (TAs) are not included in this analysis. Of the 78 NDAs, 36 are oral solids, including tablets, capsules, films, oral suspensions, and three sublingual forms. Of the 36 approved NDAs for oral solid dosages [505 (b) (2)], 12 were discontinued, including all three sublingual dosage forms. Approximately 33% of oral solid dosage form NDAs [505 (b) (2)] never re...

  Contents ANDA approvals in January 2025 General information GDUFA And Facility Readiness: A New Era for Generic Drug Approvals Advised by former Novo Nordisk boss: Biotech company turns weight-loss drug into robotic tablet Intellectual Property Melinta Therapeutics, LLC v. Nexus Pharm   ANDA approvals in January 2025   We follow ANDA approvals every month. This month, the FDA reported 64 ANDA approvals and 23 tentative approvals. These 23 products cannot be made available to patients immediately. A tentative approval is a notification issued by the FDA for drugs that otherwise meet the statutory and regulatory requirements for approval but cannot be marketed in the United States due to patents or exclusivities related to the reference-listed drug. Additional information about tentative approvals can be found on the FDA site. Here General information   GDUFA And Facility Readiness: A New Era for Generic Drug Approvals Under GDUFA III, the concept of facility readine...