Drug maker Dr Reddy’s Laboratories today said the company is all set to launch generic version of Valcyte (Valacyclovir Hydrochloride) in the U.S. market soon.
Valganciclovir Hydrochloride is prescribed to patients with acquired immunodeficiency syndrome (AIDS) for the treatment of cytomegalovirus (CMV) retinitis (When CMV virus infects the eyes, it is called CMV retinitis).
The US Food and Drug Administration (FDA) has granted final approval to Dr Reddy’s to make cheaper copies of Roche Holding AG’s antiviral Valcyte.
“As discussed, on Valcyte, we confirm that launch is expected shortly. We cannot confirm on the timeline yet,” a DRL spokesperson told PTI in an email statement.
The Hyderabad-based drug maker is set to gain with this approval. The FDA had earlier cancelled the tentative approval given for the drug to Ranbaxy on quality issues pertaining to its facilities.
The cancellation of tentative approval also led to Ranbaxy losing its 180-day exclusivity for its Abbreviated New Drug Applicatyion (ANDA).
“However, the FDA has rescinded the previously granted tentative approvals for Ranbaxy’s ANDAs for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg and for valganciclovir hydrochloride tablets USP, 450 mg.
The FDA has said that its original decisions granting tentative approvals were ‘in error’ because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted.
As a consequence, in FDA’s view, Ranbaxy has forfeited its eligibility for 180-day exclusivity for its ANDA for valganciclovir Hydrochloride tablets USP, 450 mg, Ranbaxy said yesterday.
Analysts expect that the grant of final approval to Dr Reddy’s would fetch the company $30 to 40 million sales.
“Valcyte is a USD 500mn sale in U.S. and hence can add at least USD 30-40 mn to the sales of the company. We maintain our buy on the stock with a price target of Rs 3,723,” Sarabjit Kour Nangra (VP Research-Pharma), Angel Broking said.
Shares of Dr Reddy’s gained 4.51 per cent to end at Rs 3,400 apiece on the BSE.