Gabapentin Tablets Received Tentative Approval from FDA

Zydus`s Gabapentin 300 mg and 600 mg tablets (once-daily) received tentative approval from the United States (US) Food and Drug Administration (FDA).

The medicine is indicated for the management of patients with Postherpetic Neuralgia (PN). Gabapentin will be manufactured at Moraiya in Gujarat, the company`s formulation manufacturing facility.

Tablets of Gabapentin are supplied in the strength of 300 mg and 600 mg and intended to be taken once daily for the management of the disease Postherpetic Neuralgia (PN).

The company stated that the medicinal product is the generic alternative/equivalent of Gralise tablets.

What is Postherpetic Neuralgia (PN):

Postherpetic Neuralgia (PN) is a condition of shingles infection (also known as herpes zoster). Shingles is occurs due to the reactivation of varicella–zoster virus, the same virus that is responsible for causing chickenpox.

Shingles result in a painful, blistering rash and other manifestations. The rash commonly appears in a band pattern on the single side of the body, usually on the trunk (central core of the body). The rash turns into blisters.

As the blisters/rash disappear, pain may endure. When pain endures, the condition is usually known as Postherpetic Neuralgia (PN).

In other words, Postherpetic Neuralgia (PN) is a complication in which individuals experience enduring or lasting pain in the parts of their skin affected by shingles. Persons older than 50 years of age are at risk of getting Postherpetic Neuralgia (PN).

Reference:

https://www.business-standard.com/article/news-cm/zydus-receives-usfda-tentative-approval-for-gabapentin-tablets-123022000209_1.html