Drug Approval | June 12, 2022
Strides receives USFDA approval for Ibuprofen OTC oral suspension
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
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)
The production suspension impacts commercial and clinical trial supply
WHO’s post EUA inspection found deficiencies in Good Manufacturing Practice at the facility
The product will be manufactured at Lupin’s facility in Goa, India
Potassium chloride is used to prevent or to treat low blood levels of potassium
The drug is indicated for mild and transient episodes of heart block
The Banzel Tablets, 200 mg and 400 mg market2 achieved annual sales of approximately $285.3 million.
The product patent has been already filed under fast track approval
Penicillamine Tablets USP, 250 mg (RLD: Depen) had estimated annual sales of USD 5 million in the U.S. (IQVIA MAT December 2020).
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