Strides receives US FDA approval for gabapentin tablets USP, 600 & 800 mg
Strides Pharma Science has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for gabapentin tablets USP, 600 mg and 800 mg, from the United States Food & Drug Administration (FDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin tablets, 600 mg and 800 mg, of Viatris Specialty LLC.
Gabapentin Market Size
- Gabapentin tablets has a market size of ~US$ 140 million as per IMS.
- This approval further strengthens the company's presence in the gabapentin portfolio, complementing the existing approval of gabapentin capsules, which has a market size of US$ 208 million.
- The gabapentin tablets will be manufactured at the company’s facility in Puducherry.
- ANDA filings
- The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with US FDA, of which 235+ ANDAs have been approved.
- The company has set a target to launch ~ 60 new products over three years in the US.
About Gabapentin
Gabapentin is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain. It is a commonly used medication for the treatment of neuropathic pain caused by diabetic neuropathy, postherpetic neuralgia, and central pain.
