Explore Business Standard
Don’t miss the latest developments in business and finance.
Alembic Pharmaceuticals on Thursday said it has received final nod from the US health regulator for fenofibrate tablets, which reduces cholesterol and triglycerides in blood. "Alembic Pharmaceuticals Limited (Alembic)...has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Tablets USP, 54 mg and 160 mg. "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc (AbbVie)," the drug firm said in a BSE filing. Fenofibrate tablets have an estimated market size of USD 100 million for twelve months ending September 2019, according to IQVIA. "Fenofibrate tablets are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia," it said. Alembic .
Drug firm Alembic Pharmaceuticals on Wednesday said it has received final nod from the US health regulator for Tizanidine hydrochloride capsules, used to treat spasticity. "The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing. Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important. "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma BV," the filing said. Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of USD 28 million
Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Carbidopa and Levodopa extended-release tablets, used for treatment of Parkinson's disease. The approved products are therapeutically equivalent to the reference listed drug Sinemet CR tablets of Merck Sharp & Dohme Corp. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application Carbidopa and Levodopa extended-release tablets in the strengths of 2.5 mg/100 mg and 50mg/200 mg, Alembic said in a BSE filing. Quoting IQVIA sales data, the company said the two products had an estimated market size of USD 24 million for 12 months ended December 2018. The company said it now has a total of 94 abbreviated new drug application (ANDA) approvals from the USFDA. Shares of Alembic Pharmaceuticals were trading at Rs 511.05 apiece, down 0.08 per cent, on the BSE.
Drug firm Alembic Pharmaceuticals Tuesday said its subsidiary has received the US health regulator's nod for Glycopyrrolate tablets, used in the treatment of peptic ulcer. The company's wholly owned subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Glycopyrrolate tablets USP in the strengths of 1 mg and 2mg, Alembic Pharmaceuticals said in a BSE filing. The product is a therapeutic equivalent of Casper Pharma's Robinul and Robinul Forte tablets, it added. Quoting IQVIA data, Alembic Pharmaceuticals said Glycopyrrolate tablets USP, 1 mg and 2 mg have an estimated market size of USD 15 million for 12 months ending December 2017. The company now has a total of 81 ANDA approvals from the USFDA. The stock was trading at Rs 617.60 apiece, up 0.32 per cent, on the BSE.