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Contents Recent P-IV filings General information Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries FDA Approves Kirsty as First Interchangeable Insulin Aspart Biosimilar Intellectual Property Novartis- Siremadlin Recent P-IV filings We follow P-IV filings on the USFDA website. The US FDA published a recent list on July 5, 2025. Two ANDAs were filed with P-IV certificates. Norepinephrine Bitartrate in 5% Dextrose Injection This is an interesting P-IV filing. ANDA filer must have used Baxter’s product as RLD. On March 16, 2020, Baxter filed NDA under Section 505(b)(2) for two strengths of ready-to-administer formulations of norepinephrine bitartrate in 5% dextrose: 4 mg (16 µg/ml) and 8 mg (32 µg/ml) norepinephrine bitartrate, each of which is stored in a 250 mL infusion bag. The FDA approved the NDA on January 15, 2021, for the restoration of blood pressure in adult patients with acute hypotensive states. Baxter filed supplemental NDA ...

Contents Recent ANDA approvals General information US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions Recent FDA Drug Approval Process Events Intellectual Property HQ Specialty Pharma Corp. Vs Fresenius Kabi USA, L.L.C. Recent ANDA approvals We follow ANDA approvals. In June 2025, there are approximately 103 ANDA approvals and 21 tentative approvals. The top companies that received approvals were as follows. Some of our other observations are as follows. General information US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals. News here Recent FDA Drug Approval Process Events Stay informed on the latest biotech catalysts and regulatory activity with MarketBeat’s FDA Drug Approval Calendar. This resource tracks key m...

Contents Recent 505 (b) (2) Approvals General information Pfizer Sued for Link Between Contraceptive and Brain Tumors Unicycive Therapeutics: Navigating Regulatory Setbacks and Legal Uncertainty Intellectual Property MSN- Plecanatide Case Recent 505 (b) (2) Approvals 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 June 2025, 505 (b) (2)/NDA approvals are as follows: General information Pfizer Sued for Link Between Contraceptive and Brain Tumors Pharmaceutical company Pfizer, Inc. is facing lawsuits from approximately 400 women across the U.S. and U.K., claiming they developed brain tumors from Depo-Provera – Pfizer’s hormonal bir...

  Contents Competitive Generic Therapy (CGT) approvals General information CytoSorbents Files Appeal with U.S. FDA for Supervisory Review of its De Novo Request for DrugSorb™-ATR Enlarged Board of Appeal harmonises EPO and UPC legislation 6 Intellectual Property AbbVie Biotherapeutics Inc. & Anr. vs Assistant Controller Of Patents- (Telisotuzumab vedotin) 7 Competitive Generic Therapy (CGT) approvals We follow CGT approvals. CGT designation: The Office of Generic Drugs provides a public list of all approved abbreviated new drug applications (ANDAs) for drug products with a Competitive Generic Therapy (CGT) designation and indicates which ANDAs on this list cover drug products eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act, of 180 days. This list is updated bi-weekly with new ANDA approvals where at least one of the drug products, such as one of the strengths in the approved application, received a CGT designation. Eligible for CGT Exc...