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Alembic Pharmaceuticals announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Lyrica Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg, of PF Prism CV.
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 offibromyalgia and management of neuropathic pain associated with spinal cord injury.
Alembic had previously received tentative approval for this ANDA. Pregabalin Capsules have an estimated market size of US$ 5.47 billion for twelve months ending December 2018 according to IQVIA.
Alembic now has a total of 98 ANDA approvals (88 final approvals and 10 tentative approvals) from USFDA.
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