Sidvim LifeSciences Private Limited

Contents Recent FDA approvals- Givinostat General information Exelixis (EXEL) Settles Cabometyx Patent Litigation With Cipla Emcure, Gennova settle legal dispute with US-based HDT Bio, sign agreement Intellectual Property Viagra-Vigoura Trademark Dispute-A decision by Delhi High Court Recent FDA approvals- Givinostat We follow FDA approvals In March 2024, FDA approved Givinostat, a medication used for the treatment of Duchenne muscular dystrophy. It is solid under brand name Duvyzat. DUVYZAT (givinostat) oral suspension contains givinostat hydrochloride monohydrate, a histone deacetylase inhibitor.  Givinostat hydrochloride monohydrate is designated chemically as: [6-(diethylaminomethyl)naphthalen-2-yl]methyl[4(hydroxycarbamoyl) phenyl] carbamate hydrochloride monohydrate.  Givinostat hydrochloride monohydrate is a white to off-white, non-hygroscopic, crystalline powder that is very slightly to slightly soluble in aqueous media and slightly soluble in ethanol. DUVYZAT contains gi

  Contents Recent P-IV filings reported at USFDA websites General information Dr. Reddy’s Addresses USFDA Inspection Observations US FDA continues high pace in April with 26 drug approvals Intellectual Property T 0147/22 (TAS-102 formulation/TAIHO) Recent P-IV filings reported at USFDA websites Drug, Dosage, Strength, RLD, NDA      Date of Submission Number of filers Comments  Acalabrutinib Maleate. Tablets 100 mg. Calquence 216387 13-Feb-24 1 This was originally Acerta Pharma's product. In 2016 AstraZeneca acquired a majority equity stake and secured an access to a likely best-in-class irreversible oral Bruton's tyrosine kinase (BTK) inhibitor, acalabrutinib.  Acalabrutinib is estimated to reach potential peak-year sales in excess of $5 billion globally. Five generic companies have earlier filed ANDA for acalabrutinib capsules. One of them could have filed for the tablet. Avibactam Sodium and Ceftazidime. For Injection 0.5 g/2 g per vial. Avycaz 206494 26-Feb-24 2 Ma