1.) Recent 505 (b) (2) filings 2.) Allergan Vs. Sandoz
Contents Recent 505 (b) (2) filings General information TQ Therapeutics GmbH Enters into Technology Access Agreement with Kytopen Delhi High Court refuses to restrain Dr Reddy's from manufacturing, exporting Ozempic like drug Intellectual Property Allergan Vs. Sandoz 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 . In November 2025, a tentative approval was granted for the Ruxolitinib NDA (#219660) for Apotex. Ruxolitinib tablets are marketed as ruxolitinib phosphate salt under the brand name Jakafi. We are trying to understand why Apotex filed an NDA instead of an ANDA. There is one new strength, 2 MG, but other str...