Drug major Cipla Monday said it has received final approval from the US health regulator for Valganciclovir tablets, used in the treatment of viral eye infection in AIDS patients.
Drug major Cipla Monday said it has received final approval from the US health regulator for Valganciclovir tablets, used in the treatment of viral eye infection in AIDS patients.
Valganciclovir tablets, are used in the treatment cytomegalovirus infection (serious viral eye infection of the retina) in AIDS patients and in prevention of cytomegalovirus (CMV) disease after organ transplant.
The approved products is a generic therapeutic equivalent version of Roche's Valcyte.
Cipla has received approval for the product in the strength of 450 mg from the United States Food and Drug Administration (USFDA), the company said in a BSE filing.
Quoting IQVIA (IMS Health) data, Cipla said Valcyte and its generic equivalents had US sales of around USD 79 million for the 12-month period ending September 2018.
Shares of Cipla were trading 1.09 per cent higher at Rs 532.95 apiece on BSE.
Earlier, Drug maker Cipla Ltd on Monday said "multiple headwinds" are likely to impact the company's performance in the second half.Revenue growth during the July-September period decreased 1.71% to Rs 4,012 crore, while Ebitda (earnings before interest, taxes, depreciation and amortisation) fell 6.34% to Rs 753 crore over the same period last fiscal.
In a statement, Cipla managing director and global chief executive officer Umang Vohra said the company had a modest quarter but maintained a strong performance in private market segment across geographies, and its limited competition assets in the US are ramping up to drive quarter-on-quarter growth.
"As we enter the second half of this fiscal, multiple headwinds are likely to impact our reported performance. Having said that, we are focusing on positioning our businesses for long-term growth," he further said.
Though pricing pressure remained in the United States, Cipla's North America business grew 23% in the July-September quarter. Domestic sales were flat at Rs 1,644 crore as compared to Rs 1,645 crore in the year-ago period. Sales during Q2 FY2019 in Europe and South Africa fell 7% and 3%, respectively.
The street was expecting Cipla to report a net profit of around Rs 450 crore for the July-September quarter.
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 "Cipla gets USFDA nod for anti-viral eye infection drug for AIDS patients")
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