Drug Approval | August 13, 2022
Lupin receives USFDA approval for Meclizine Hydrochloride Tablets USP
The product will be manufactured at Lupin’s facility in Goa, India.
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
Strides is the first Indian company to get approval for the product.
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.
The drug will be manufactured at the group’s topical facility at Ahmedabad
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)
Manamed, a pioneering Medical Technology development company, has been granted FDA approval on its latest orthopaedic recovery device, ManaSport.
Pemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)
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