Zydus gets USFDA tentative nod for Gabapentin Tablets

Zydus gets USFDA tentative nod for Gabapentin Tablets

Zydus Subsidiary Receives USFDA Tentative Approval for Gabapentin Tablets for Postherpetic Neuralgia Management

Zydus Lifesciences, along with its subsidiaries and affiliates, referred to as Zydus, has announced that its subsidiary, Zydus Pharmaceuticals (USA) Inc., has received tentative approval from the United States Food and Drug Administration (USFDA) for Gabapentin Tablets (Once-Daily), 300 mg and 600 mg (USRLD: Gralise® Tablets).

The drug is indicated for the management of Postherpetic Neuralgia (PHN), and it will be manufactured at the group’s formulation manufacturing facility located in Moraiya. Gabapentin Tablets have had annual sales of USD 90 mn in the United States (IQVIA MAT Dec. 2022).

This approval marks a significant milestone for Zydus as the group now has 343 approvals and has filed over 440* ANDAs since the beginning of the filing process in FY 2003-04.

With this latest development, Zydus is well positioned to provide patients in need with a new and effective treatment option for managing PHN, a debilitating condition that affects millions of people worldwide. Stay tuned for more updates on this exciting development from Zydus.

About Zydus Lifesciences:

In 1995, the group was restructured and thus was formed Cadila Healthcare under the aegis of the Zydus group. From a humble turnover Rs. 250 crores in 1995 the group witnessed a significant financial growth and registered a turnover of over Rs. 14,253 crores in FY20.
Adhering to its brand promise of being dedicated to life in all its dimensions, Zydus continues to innovate with an unswerving focus to address the unmet healthcare needs. Simultaneously it rededicates itself to its mission of creating healthier, happier communities across the globe.

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