Zydus Cadila gets USFDA nod to antihistamine Meclizine Hydrochloride Tablets
Meclizine is an antihistamine that is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It may also be used to reduce dizziness and loss of balance (vertigo) caused by inner ear problems.
Ahmedabad: Drug firm Zydus Cadila recently said that the company has received a nod from the US health regulator to market generic antihistamine Meclizine hydrochloride tablets (US RLD: Antivert Tablets).
The drugmaker has received final approval from the United States Food and Drug Administration (USFDA) to market Meclizine hydrochloride tablets in the strengths of 12.5 mg and 25 mg.
Meclizine is an antihistamine that is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It may also be used to reduce dizziness and loss of balance (vertigo) caused by inner ear problems.
The drug will be manufactured at the group's manufacturing facility at SEZ, Ahmedabad.
The group now has 292 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India. The company discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.
Read also: Zydus Cadila gets final USFDA nod for Deferasirox Tablets to treat iron overload syndrome
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