Drug firm Alembic Pharmaceuticals Monday said it has received approval from the US health regulator for Pregabalin Capsules, indicated for management of neuropathic pain associated with certain illnesses.
The approved product is therapeutically equivalent to the reference listed drug Lyrica Capsules of PF Prism CV.
The approval from the United States Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Pregabalin Capsules in the strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg, Alembic Pharmaceuticals said in a filing to BSE.
Quoting IQVIA data, Alembic Pharma said Pregabalin Capsules have an estimated market size of $5.47 billion for 12 months ending December 2018.
Pregabalin Capsule is indicated for management of neuropathic pain associated with diabetic peripheral neuropathy, management of postherpetic neuralgia, adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older, management of fibromyalgia and management of neuropathic pain associated with spinal cord injury.
The company currently has a total of 98 ANDA approvals (88 final approvals and 10 tentative approvals) from USFDA, it added.
Shares of Alembic Pharma were trading 1.08 per cent lower at Rs 513 apiece on BSE.