New Delhi : 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 (USFDA) 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 firm AstraZeneca Pharmaceutical Company in the same strengths, it added.
The tablets are indicated for acute treatment of migraine in adults, Alembic Pharma said.
The company currently has 51 ANDA approvals (45 final and 6 tentative) from USFDA.
Alembic Pharma stock was trading 0.03 per cent higher at Rs 632.45 in the morning trade on BSE.