Sun Pharma Gets CDSCO Panel Nod to Manufacture, Market Gabapentin for neuropathic pain
New Delhi: Pharmaceutical major Sun Pharma has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market Gabapentin extended released (ER) tablets 300mg/600mg for the treatment of neuroleptic pain as an additional indication.
This came after the drug major Sun Pharma Laboratories presented the proposal for the grant of manufacturing and marketing permission of Gabapentin ER tablets 300mg/600mg for the treatment of neuropathic pain as an additional indication along with the clinical trial waiver justification and clinical trial data of other countries, before the committee.
Gabapentin is an anticonvulsant medication used in the management of peripheral neuropathic pains, postherpetic neuralgia, and partial-onset seizures. Gabapentin is a structural analogue of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA).
It inhibits the release of excitatory neurotransmitters, allowing for its use against pathologic neurotransmissions such as that seen in neuropathic pain and seizure disorders.
At the recent SEC meeting for Neurology and Psychiatry held on 13th June 2023, the expert panel reviewed the proposal presented by Sun Pharma Laboratories for the grant to manufacture and market Gabapentin extended released tablets 300mg/600mg for the treatment of neuroleptic pain as an additional indication along with the clinical trial waiver justification and clinical trial data of other countries.
The committee noted that the product is already approved in India and USA and the firm is also holding manufacturing and marketing permission for Gabapentin ER tablets 300mg/600mg for the management of post-herpetic neuralgia.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of Gabapentin ER tablets 300mg/600mg for the treatment of neuropathic pain as an additional Indication.
