Indian generics giant Alembic Pharmaceuticals Limited (Alembic) has received the approval of the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg. “The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Zaroxolyn Tablets 2.5 mg, 5 mg, and 10 mg, of the Lannett Company, Inc,” said the company release.
USFDA defines abbreviated new drug application (ANDA) as an application that contains data for the review and potential approval of a generic drug product. Once approved, the generic drug can be manufactured and marketed as a lower-cost alternative to the brand-name drug it references.
Metolazone Tablets are indicated for the treatment of salt and water retention including edema during congestive heart failure and renal diseases, including the nephrotic syndrome and states of diminished renal function. Edema is swelling of a part of the body due to fluid buildup in the tissues.
Metolazone Tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size of US$ 33 million for twelve months ending September 2020 according to IQVIA.
On 1st December, Alembic had announced the USFDA approval for an Investigational New Drug (IND) application by its Switzerland based associate Rhizen Pharmaceuticals to study the RP7214 oral Dihydroorotate dehydrogenase (DHOHD) inhibitor for SARS-CoV-2 infection. The company said that initial study will involve single ascending doses of RP7214 in healthy volunteers and that dosing is expected to begin in early December 2020. In short, Rhizen aims to produce an oral antiviral drug suitable for Covid-19 treatment across all hospital and out-patient settings.
As of date, Alembic has a cumulative total of 137 ANDA approvals (118 final approvals and 19 tentative approvals) from USFDA.