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Alembic Pharma gets US FDA nod

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Zolmitriptan orally disintegrating tablets are used for the treatment of migraine

Alembic Pharmaceuticals has received approval from the US health regulator for Zolmitriptan Orally Disintegrating tablets, used for the treatment of migraine, in the American market.

“The company has received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Zolmitriptan Orally Disintegrating tablets, 2.5 and 5 mg,” Alembic Pharmaceuticals said in a BSE filing.

The product is therapeutically equivalent to the reference listed drug product (RLD) Zolmig-ZMT Orally Disintegrating tablets of AstraZeneca Pharmaceutical Company in the same strengths, it added.

The tablets are indicated for acute treatment of migraine in adults, Alembic Pharma said.

PTI

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