Lamotrigine - newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu & Kashmir, Trending news | News Mantra https://newsmantra.in/tag/lamotrigine/ Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu & Kashmir, Trending news | News Mantra Fri, 04 Oct 2024 11:48:24 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.3 https://newsmantra.in/wp-content/uploads/2019/05/cropped-newmantra-logo-32x32.png Lamotrigine - newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu & Kashmir, Trending news | News Mantra https://newsmantra.in/tag/lamotrigine/ 32 32 Alembic Pharmaceuticals announces USFDA Final Approval for Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg. https://newsmantra.in/alembic-pharmaceuticals-announces-usfda-final-approval-for-lamotrigine-extended-release-tablets-usp-200-mg-250-mg-and-300-mg/ Fri, 04 Oct 2024 11:48:24 +0000 https://newsmantra.in/?p=47270 3rd October 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final 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 approved ANDA is therapeutically equivalent to the reference listed drug...

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]]> 3rd October 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final 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 approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK).

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. 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. Refer label for a detailed indication.

Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg have an estimated market size of US$ 163 million for twelve months ending June 2024 according to IQVIA.

Alembic has a cumulative total of 216 ANDA approvals (188 final approvals and 28 tentative approvals) from USFDA.

The post Alembic Pharmaceuticals announces USFDA Final Approval for Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg. appeared first on newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu & Kashmir, Trending news | News Mantra.

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