Unichem Laboratories receives USFDA approval for hypertension drug

Unichem Laboratories has received the approval from USFDA for Irbesartan tablets USP indicated to treat hypertension. The product will be commercialized from Unichem's Ghaziabad plant. Active Pharmaceutical Ingredient (APIs) will also be made in house at Pithampur API plant, the company said in a statement, as reported by Business Standard.

Also read: Unichem gets USFDA nod for hypertension treatment tablets

It has received final Abbreviated New Drug Application (ANDA) approval to manufacture the drug in the strengths of 75 milligram (mg), 150mg and 300mg. These drugs are therapeutically equivalent to Avapro tablets, 75mg, 150mg and 300mg of Sanofi-aventis U.S.LLC.

For hypertension, the drug can be used as a single pill or in combination with other antihypersensitive agents. The tablets are therapeutically equivalent to Sanofi- -aventis's Avapro tablets, which are indicated for the treatment of hypertension. It is also used for the treatment of diabetic nephropathy, as reported by DNA.

Diabetic nephropathy is indicated to be treated by using an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, Irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation).

Net profit of Unichem Laboratories rose 3.45% to Rs 23.09 crore on 10.39% rise in net sales to Rs 303.52 crore in Q2 September 2015 over Q2 September 2014.