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01/21/2022

Alembic receives tentative nod for 2 generics

Alembic has received tentative approval from the Food and Drug Administration for dronedarone tablets and vortioxetine tablets.
Sandra Levy
Senior Editor
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Alembic has received tentative approval from the Food and Drug Administration for dronedarone tablets.

The medication is the generic of Sanofi-Aventis' Multaq.

Dronedarone is indicated to reduce, the risk of hospitalization for atria) fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.

[Read more: Alembic obtains FDA nod for 2 generics]

The tablets have a market value of roughly $500 million for the 12 months ending September 2021, according to IQVIA.

The FDA also has given Alembic tentative approval for vortioxetine tablets in dosage strengths of 5 mg, 10 mg, 15 mg and 20 mg.

The medication is the generic of Takeda’s Trintellix.

[Read more: Alembic launches generic Anafranil]

Vortioxetine tablets are indicated for the treatment of a major depressive disorder.

Vortioxetine tablets, 5 mg, 10 mg, 15 mg, and 20 mg have a market value of roughly $1.2 billion for the 12 months ending September 2021, according to IQVIA.

Alembic noted that it is currently in litigation with H.Lundbeck in Court of Appeals for the Federal Circuit. The product launch will depend on the litigation outcome.

It is possible that Alembic’s ANDA may not be indicated for certain uses due to unexpired exclusivities for the RLD for such uses, the company said.

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