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Alembic Pharmaceuticals gets ANDA approval for Zolmitriptan Orally Disintegrating Tablets

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From USFDA

Alembic Pharmaceuticals has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Zolmitriptan Orally Disintegrating Tablets, 2.5mg and 5mg. The approved ANDA is therapeutically equivalent to the reference listed drug product, Zomig-ZMT Orally Disintegrating Tablets, 2.5mg and 5mg of AstraZeneca Pharmaceutical Company. Zolmitriptan Orally Disintegrating Tablets are indicated for the acute treatment of migraine with or without aura in adults.

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First Published: Dec 05 2016 | 11:00 AM IST

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