Close

Aurobindo Pharma receives USFDA approval for Valganciclovir tablets

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Related stories

Roche Looks to Expand its Drug Production in the US

Roche is planning to expand its drug production in...

How Language Barriers Impact Non-Native English Speakers in Healthcare

Language barriers create significant challenges for non-native English speakers...

FDA Approval of AMVUTTRA for ATTR Amyloidosis

Alnylam Pharmaceuticals, Inc., a global leader in RNAi therapeutics,...

Rina-S Shows Promise in Advanced Ovarian Cancer

Genmab has reported encouraging findings from the Phase 2...

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Valganciclovir Tablets USP, 450 mg. This product is to be launched in Q1 FY16-17.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Valcyte® of Hoffman-La Roche Inc. Valganciclovir Tablets 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.

The approved product has an estimated market size of US$ 391 million for the twelve months ending February 2016 according to IMS. This is the 69th ANDA (including 15 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 251 ANDA approvals (215 Final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.

 

Latest stories

Related stories

Roche Looks to Expand its Drug Production in the US

Roche is planning to expand its drug production in...

How Language Barriers Impact Non-Native English Speakers in Healthcare

Language barriers create significant challenges for non-native English speakers...

FDA Approval of AMVUTTRA for ATTR Amyloidosis

Alnylam Pharmaceuticals, Inc., a global leader in RNAi therapeutics,...

Rina-S Shows Promise in Advanced Ovarian Cancer

Genmab has reported encouraging findings from the Phase 2...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back