Live
- Cyberabad police bust diesel smuggling gang
- Hyderabad: Workshop held on preventing wildlife crimes
- Pulivendula: Countdown for Jagan’s fall began, says Ravi
- ‘Many bureaucrats still working as YSRCP activists’
- Sec'bad Cantt bypoll: Residents root for merger with GHMC to end woes
- Timetable out for Adv Suppl exams
- 22 TSREIS Jr colleges record 100% pass
- Rajamahendravaram: Finally, TDP-BJP solve Anaparthi conundrum
- Girl Power Unleashed! Girls eclipse boys in both Inter Ist & 2nd yr results
- Vijayawada: ‘CM slept like Kumbhakarna without filling teacher posts’
Aurobindo gets FDA nod for anti-viral drug
Aurobindo Pharma has received final approval from the US health regulator to manufacture and market anti-viral Valganciclovir tablets in the American market.
Hyderabad: Aurobindo Pharma has received final approval from the US health regulator to manufacture and market anti-viral Valganciclovir tablets in the American market. "The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Valganciclovir Tablets USP, 450 mg," Aurobindo Pharma said in statement
The firm said this product is expected to be launched in the first quarter of the current fiscal. The approved ANDA (Abbreviated New Drug Applications) is bioequivalent and therapeutically equivalent to the reference listed drug product Valcyte of Hoffman-La Roche Inc, it added. According to IMS, the approved product has an estimated market size of USD 391 million for the twelve months ending February 2016, Aurobindo Pharma said.
Valganciclovir tablet is an anti-viral used in the treatment of Cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome and prevention of CMV disease in kidney, heart or kidney-pancreas transplant patients. Aurobindo Pharma said it has also received final approval from the USFDA to manufacture and market antibiotic Vancomycin Hydrochloride for injection, used for the treatment of severe infections, in the American market.
Vancomycin Hydrochloride for injection is an antibiotic used in the treatment of severe infections caused by susceptible strains of methicillin-resistant (Beta-lactam resistant) staphylococci and others. The pharma company has a total of 251 ANDA approvals (215 final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from the US.
