Aurobindo Pharma has received final approval from the US Food and Drug Administration to manufacture and market Valacyclovir hydrochloride tablets 500mg (base) and 1g (base).
Valacyclovir hydrochloride tablets 500mg (base) and 1g (base) are the generic equivalent of GloxoSithKline's Valtrex Caplets 500mg (base) and 1g (base). Valacyclovir hydrochloride tablets falls under the anti-infective therapeutic category and is indicated for the treatment of cold sores, genital herpes and shingles in adult patients and chicken pox in paediatric patients two to 18 years of age. The product has a market size of approximately US$ 2 billion according to Newport and is ready for launch.
According to an Aurobindo press release, the company now has a total of 117 ANDA approvals (87 final approvals and 30 tentative approvals) from US FDA.