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		<title>Alembic Pharmaceuticals Limited announces USFDA Final Approval for Divalproex Sodium Delayed-Release Capsules USP, 125 mg</title>
		<link>https://newsmantra.in/alembic-pharmaceuticals-limited-announces-usfda-final-approval-for-divalproex-sodium-delayed-release-capsules-usp-125-mg/</link>
		
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		<pubDate>Fri, 20 Dec 2024 11:32:13 +0000</pubDate>
				<category><![CDATA[Health]]></category>
		<category><![CDATA[Alembic pharmaceuticals]]></category>
		<category><![CDATA[Divalproex Sodium Delayed-Release Capsules]]></category>
		<category><![CDATA[USFDA]]></category>
		<guid isPermaLink="false">https://newsmantra.in/?p=52946</guid>

					<description><![CDATA[<p>20th December, 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food &#38; Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Divalproex Sodium Delayed-Release Capsules USP, 125 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle...</p>
<p>The post <a href="https://newsmantra.in/alembic-pharmaceuticals-limited-announces-usfda-final-approval-for-divalproex-sodium-delayed-release-capsules-usp-125-mg/">Alembic Pharmaceuticals Limited announces USFDA Final Approval for Divalproex Sodium Delayed-Release Capsules USP, 125 mg</a> appeared first on <a href="https://newsmantra.in">newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu &amp; Kashmir, Trending news | News Mantra</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><strong>20<sup>th</sup> December, 2024, Bengaluru:</strong> Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food &amp; Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Divalproex Sodium Delayed-Release Capsules USP, 125 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules, 125 mg, of AbbVie Inc.</p>
<p>Divalproex Sodium is an anti-epileptic drug indicated for monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures. Refer label for a detailed indication.</p>
<p>Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA.</p>
<p>Alembic has a cumulative total of 220 ANDA approvals (193 final approvals and 27 tentative approvals) from USFDA.</p>
<p>The post <a href="https://newsmantra.in/alembic-pharmaceuticals-limited-announces-usfda-final-approval-for-divalproex-sodium-delayed-release-capsules-usp-125-mg/">Alembic Pharmaceuticals Limited announces USFDA Final Approval for Divalproex Sodium Delayed-Release Capsules USP, 125 mg</a> appeared first on <a href="https://newsmantra.in">newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu &amp; Kashmir, Trending news | News Mantra</a>.</p>
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