Vista Pharma awaits USFDA nod for launch of gDofetilide; stock surges 4.5%

The company has completed all data filings and GDUFA fee payments for 2019 and is waiting for approval from USFDA for the commercial launch of the product, Vista said in a press release.

Jan 04, 2019 08:01 IST India Infoline News Service

Vista Pharmaceuticals
Shares of Vista Pharmaceuticals surged 4.5% in afternoon trade on the BSE on Friday. The pharma company had filed an ANDA in September 2017 for Dofetilide (Brand: Tikosyn) in financial partnership with Biddle Sawyer, USA.

The drug molecule Tikosyn, owned by Pfizer, is a cardiac drug which went off patent on October 9, 2018.

“Upon approval of Dofetilide ANDA, the company will join the exclusive club of other four generic manufacturers (Sun, Greenstone, Bion,  and Mayne/Sigma),” the company said in a filing to the exchanges on Thursday.

"The size of the market is over $200mn (~Rs1,400cr). The company has completed all data filings and GDUFA fee payments for 2019 and is waiting for approval from USFDA for the commercial launch of the product," the filing added.

Vista Pharmaceuticals Ltd share price is currently at Rs30.40, up Rs1.4, or 4.83%, from its previous close of Rs29 on the BSE. The scrip opened at Rs30.45 and has touched a high and low of Rs30.45 and Rs29.25, respectively.

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