Drug Approval | August 16, 2022
Lupin receives approval from U.S. FDA for Meclizine Hydrochloride Tablets USP
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)
The product will be manufactured at Lupin’s facility in Goa, India.
Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age
Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.
Strides is the first Indian company to get approval for the product.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
The product will be manufactured at Lupin's facility in Nagpur, India.
Bisoprolol Fumarate Tablets are used to treat high blood pressure.
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