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Contents New Drugs Approved by CDSCO General information Hearing Against Pfizer Set For 29 September In Contraceptive ‘Depo-Provera’ Multidistrict Litigation FDA Initiates Approval Process for Leucovorin Calcium as Potential Autism Treatment Intellectual Property Jazz Pharmaceuticals, Inc. and Avadel CNS Pharmaceuticals, LLC.- Sodium oxybate New Drugs Approved by CDSCO Generally, we follow the US FDA's approvals every month. This week, we decided to check what is happening in India. Therefore, we reviewed recent approvals from the Central Drugs Standard Control Organisation (CDSCO). We examined approvals from the past three months. The list of new drugs approved in 2025 so far can be found here . General information Hearing Against Pfizer Set For 29 September In Contraceptive ‘Depo-Provera’ Multidistrict Litigation Global pharmaceutical company Pfizer Inc. (NYSE:PFE), manufacturer of contraceptive injection Depo-Provera (DMPA), is facing a multidistrict litigation (MDL No. ...

Contents ANDA approvals in August 2025 General information Lilly Chooses Virginia Site for $5B API Manufacturing Facility, with ADCs in Mind GSK commits $30 billion to US research and development, factory expansion, as Trump visits UK Intellectual Property Amgen Inc. Vs Sandoz Inc ANDA approvals in August 2025 We follow ANDA approvals. In August, a total of 63 ANDA approvals were issued, of which 12 were tentative. A tentative approval is a formal notification from the USFDA indicating that a generic drug application has met all scientific and regulatory requirements for safety, efficacy, and quality, but cannot be granted final marketing approval due to unexpired patents or market exclusivities held by the original brand-name drug. The companies that sought more than 2 ANDA approvals (including tentative) were as follows. Some of our observations are as follows. General information Lilly Chooses Virginia Site for $5B API Manufacturing Facility, with ADCs in Mind Elli Lil...

Contents Recent 505 (b) (2) filings General information BioNTech and Pfizer strike back against GSK in London US FDA stepping up enforcement of pharma ad rules, sends letters to companies Intellectual Property N.V. Nederlandsch Octrooibureau vs Diazyme Laboratories, Inc. Recent 505 (b) (2) filings We follow 505 (b) (2) approvals every month. Generally, 505(b)(2) NDAs pertain to changes in comparison to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). For more details on 505(b)(2) FDA approvals, please visit this link . The details of August 2025, 505 (b) (2)/NDA approvals are as follows: General information BioNTech and Pfizer strike back against GSK in London The backlash from BioNTech and Pfizer was not long coming. After GSK sued the two manufacturers of the COVID-19 vaccine Comirnaty at the UPC and in Ireland, Pfizer ...

Contents Recent P-IV filings General information Compounding Of Offences Under Drugs And Cosmetics Laws: A Legal Shift In 2025 Aptar Digital Health Partners with AstraZeneca to License AI Algorithms for Chronic Kidney Disease Detection Intellectual Property Stamicarbon B.V. Vs Thyssenkrupp Fertiliser Technology GmbH Vs Recent P-IV filings We follow P-IV certificate filings. The FDA published its last such list on August 18, 2025. The list can be accessed here . General information US FDA proposes new process to accelerate approval of drugs for rare diseases. The U.S. Food and Drug Administration on proposed a new process to streamline the approval of drugs targeting rare diseases with very small patient populations, including cases supported by data from single-arm clinical trials. The regulator said eligibility will be based on whether the disease affects a small population – fewer than 1,000 individuals in the United States – and is intended to treat a genetic defect. News ...