Granules India Receives ANDA Approval for Losartan and Hydrochlorothiazide Tablets

Granules have a total of 60 ANDA approvals from the US FDA (58 final and 2 tentative approvals)

Losartan and Hydrochlorothiazide Tablets Uses

Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of

  •  Hypertension to lower blood pressure and
  • Reduce risk of stroke in patients with hypertension and left ventricular hypertrophy

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Hyzaar Tablets of Organon LLC. Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension to lower blood pressure and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. Granules now have a total of 60 ANDA approvals from US FDA (58 Final approvals and 2 tentative approvals). The current annual U.S. market for Losartan and Hydrochlorothiazide Tablets is approximately $73 Million, according to MAT Jul 2023, IQVIA/IMS Health.

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