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The US health regulator has provided its approval to the Alembic Pharmaceuticals for Zolmitriptan Orally Disintegrating tablets that are used for treating migraine.
It has said in a BSE filing that “The company has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Zolmitriptan Orally Disintegrating Tablets, 2.5 and 5 mg.”
It added that the product is therapeutically equivalent to the reference listed drug product (RLD) Zolmig-ZMT Orally Disintegrating tablets of firm AstraZeneca Pharmaceutical Company in the same strengths.
