Sidvim LifeSciences Private Limited

  Contents FDA approval in February 2023. General information Zevra to get US patent linked to sleep disorder therapy Bayer to Spend $1 Billion on US Drug R&D Intellectual Property Orkla Health Vs Hyben Vital Licens ApS FDA approval in February 2023 We follow FDA approvals for small molecules.  Travere gets FDA accelerated approval for FILSPARI ( Sparsentan ) for proteinuria in IgAN Jefferies is predicting Filspari will reach $35 million in sales this year, and $745 million at peak. Here Sparsentan is a white to off-white powder, which is practically insoluble in water. Sparsentan has pH-dependent solubility, with intrinsic solubility of 1.48 and 0.055 mg/mL under pH 1.2 and 6.8, respectively. FILSPARI is available as film-coated 200 mg and 400 mg strength immediate release tablets for oral administration.  The inactive ingredients in FILSPARI are colloidal silicon dioxide, lactose anhydrous, magnesium stearate, silicified microcrystalline cellulose, and sodium starch

  Contents ANDA approvals in February 2023 General information Handling HPAPIs safely – what does it take? Leading innovators in tyrosine kinase inhibitors for the pharmaceutical industry Intellectual Property Sensile Pat AG Vs Eveon: Appeal Board decision at EPO ANDA approvals in February 2023 We follow ANDA approvals, especially of Indian companies. In February 2023 in total there are more than 70 ANDA approvals. Out of which about 20 are tentative approvals.  Eugia and Aurobindo received total 7 approvals. Zydus received total 5 approvals. Ajanta, Hetero, Mankind received 2 each.  Some of our observations are as below.  Drug Name Company Sidvim Comments VORICONAZOLE. ANDA  #212162 EUGIA PHARMA This is 200 MG/Vial. There are seven other approvals. This is mainly hospital use. It is used to treat certain serious fungal or yeast infections SUCCINYLCHOLINE CHLORIDE.         ANDA  #216127 MANKIND PHARMA There are several other Gx approved. Succinylcholine chloride is indicate