FDA Approves Ohm Laboratories’ Generic Valsartan (ANDA 077492)

The U.S. Food and Drug Administration has approved the Abbreviated New Drug Application (ANDA) 077492 for generic valsartan tablets submitted by Ohm Laboratories Inc. The approved product is marketed under the brand name Valsartan and is available in oral tablet form in four strengths – 40 mg, 80 mg, 160 mg, and 320 mg – with product numbers 001 through 004. The tablets are listed under multiple NDC codes, including 51660‑140‑03, 51660‑141‑03, 51660‑142‑03, and 51660‑143‑03. The approval follows a series of labeling submissions: an original labeling submission in July 2014, additional labeling updates in December 2015, and a labeling submission in August 2019, all reviewed with standard priority. Valsartan is classified as an angiotensin II receptor blocker (ARBs) and is indicated for hypertension. The generic is designated as a prescription human drug.