<p>New Delhi: Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic medication for seizures.</p>.<p>The company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine extended-release tablets (USP 200 mg, 250 mg, and 300 mg), the drug firm said in a regulatory filing.</p>.<p>The approved ANDA is therapeutically equivalent to GlaxoSmithKline LLC's Lamictal XR extended-release tablets in strength of 200 mg, 250 mg, and 300 mg, it added.</p>.Apple gets FDA nod to bring sleep apnoea detection feature to its smartwatches.<p>Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalised tonic-clonic seizures and partial-onset seizures with or without secondary generalisation in patients aged 13 years and older.</p>.<p>The drug is also indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug.</p>.<p>According to IQVIA, Lamotrigine Extended-Release Tablets (200 mg, 250 mg, and 300 mg) have an estimated market size of USD 163 million for twelve months ending June 2024.</p>.<p>The company said it now has a cumulative total of 216 ANDA approvals from the USFDA. </p>
<p>New Delhi: Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic medication for seizures.</p>.<p>The company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine extended-release tablets (USP 200 mg, 250 mg, and 300 mg), the drug firm said in a regulatory filing.</p>.<p>The approved ANDA is therapeutically equivalent to GlaxoSmithKline LLC's Lamictal XR extended-release tablets in strength of 200 mg, 250 mg, and 300 mg, it added.</p>.Apple gets FDA nod to bring sleep apnoea detection feature to its smartwatches.<p>Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalised tonic-clonic seizures and partial-onset seizures with or without secondary generalisation in patients aged 13 years and older.</p>.<p>The drug is also indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug.</p>.<p>According to IQVIA, Lamotrigine Extended-Release Tablets (200 mg, 250 mg, and 300 mg) have an estimated market size of USD 163 million for twelve months ending June 2024.</p>.<p>The company said it now has a cumulative total of 216 ANDA approvals from the USFDA. </p>