Vista Pharmaceuticals has completed all data filings and up to date in GDUFA fee payments for 2019 and is waiting for approval from USFDA for commercial launch of generic Dofetilide.
Vista Pharmaceuticals had filed an ANDA in September 2017 Dofetilide (Brand: TIKOSYN) in financial partnership with Biddle Sawyer, USA.
TIKOSYN (Generic: Dofetilide) is a CARDIAC drug which went OFF PATENT on October 09, 2018 and the drug molecule, TIKOSYN is owned by Pfizer.
Upon approval of Dofetilide ANDA, the company will join the exclusive club of other 4 Generic Manufacturers (Sun, Greenstone, Bion, Mayne/Sigma). The size of the market is over $ 200 million (Rs 1,400 crore approximately).
Vista Pharmaceuticals is engaged in manufacturing and selling of pharmaceutical, medical and veterinary preparations. The company also sells the products to its related companies, which are engaged in the manufacture of formulations.