Lyrus Receives US FDA approval for Critical UTI treatment in the US
ANDA Approval for Methenamine Hippurite
Lyrus has received US FDA approval for our Abbreviated New Drug Application (ANDA) for 'Methenamine Hippurate Tablets USP, 1 gram', an AB-rated, substitutable generic version of Hiprex®.
This approval marks a major milestone for Lyrus in the US market. It demonstrates our capabilities in bringing complex generics and difficult-to-manufacture products to patients who need them. Methenamine Hippurate is indicated for the prophylactic or suppressive treatment of frequently recurring urinary tract infections (UTIs) when long-term therapy is considered necessary. UTIs affect millions of patients globally each year, so there is a growing need for treatment options. Our rigorous analyses submitted to the FDA showed that Lyrus’ product has the same active ingredient, dosage form, route of administration and strength as the branded version. It will be produced in India and marketed in the US by our partner Jubilant Cadista Pharmaceuticals Inc.
Methenamine is used to prevent or control returning urinary tract infections caused by certain bacteria. It is not used to treat an active infection. Antibiotics must be used first to treat and cure the infection. Methenamine is a drug that stops the growth of bacteria in urine. This medication also contains an ingredient that helps to make the urine acidic. When the urine is acidic, methenamine turns into formaldehyde to kill the bacteria. This drug is effective only against bacterial infections in the urinary tract. It will not work for other types of bacterial infections (such as in the blood) or for viral infections (such as the common cold or flu). Unnecessary use or misuse of any antibacterial drug can lead to its decreased effectiveness.
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