Current screening programs implemented in some hospitals, called "targeted screening," in which babies who fail newborn screening programs are tested for CMV, are not sufficient to achieve the goal of identifying babies who will need follow-up for early detection of SNHL or vision abnormalities, or possibly early antiviral therapy (Valcyte
; valganciclovir), because only a small portion of those who eventually develop SNHL are currently identified by the targeted screening programs.
He has also served as counsel for numerous generic pharmaceutical manufacturers, and has been instrumental in developing and implementing strategies for achieving early market entry of numerous generic products including atorvastatin (Lipitor) an valganciclovir (Valcyte
Reddy's, the Hyderabad-based NYSE-listed pharma major, launched the generic version of Valcyte
in the US - it's the brand of Swiss major Roche for this anti-viral medication.
Aurobindo also received final approval for rivastigmine tartrate capsules USP, 1.5, 3, 4, 5 and 6 mg, the generic equivalent to Novartis Pharmaceuticals Corp.'s Exelon and for valganciclovir tablets USP, 450 mg, the generic equivalent to Valcyte
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.
If the HHV-6 IgG level is 1:640 (or four) or higher, or if the CMV IgG is >4, I consider a 6-month treatment trial with Valcyte
if the person has not adequately responded to other treatments.
The company said that the US Food & Drug Administration (USFDA) approved Valganciclovir Tablets USP 450 mg are a therapeutic equivalent generic version of VALCYTE
(184) This landmark ruling renewed hope for the ongoing patent oppositions regarding other ARV drugs in India such as Reyataz (atazanavir), Sustiva (efavirenz), Valcyte
(valganciclovir), and Viread (tenofovir).
(5) In 2010, the Indian Patent Office set aside the patent for Roche's drug Valcyte
(valganciclovir hydrochloride) as lacking an inventive step and not showing increased therapeutic efficacy.
Roche created, patented and marketed the l-valine ester of ganciclovir under the trade name Valcyte
. (13) Several organizations mounted a post-grant challenge of Roche's patent on Valcyte
FDA Issues New Dosing Guidance for Children Using Valcyte