USFDA gives nod for this generic drug to lower cholesterol levels

The drug will be manufactured at the group's formulation manufacturing facility at Moraiya in Gujarat, the company stated.

145
USFDA Approval
USFDA Approval

Last Updated on October 11, 2024 by The Health Master

New Delhi: Zydus Lifesciences said it has received an approval from the US health regulator to market a generic medication to lower high cholesterol levels.

The company has received final approval from the US Food and Drug Administration (USFDA) to market Pitavastatin tablets in strengths of 1 mg, 2 mg, and 4 mg, the drug maker said in a statement.

The company’s product is the generic equivalent of Livalo tablets.

Pitavastatin is a HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C).

It is also indicated for pediatric patients aged 8 years or older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya in Gujarat, the company stated.

As per IQVIA MAT Dec data, Pitavastatin tablets (1 mg, 2 mg, and 4 mg) had annual sales of USD 319 million in the US.

USFDA approves bleeding disorder therapy

USFDA issues EIR to Strides for Bangalore facility

Hyderabad is having maximum USFDA approved Pharma Units in world

USFDA gives tentative nod for Gabapentin Tablets, 300 mg and 600 mg

USFDA gives approval for Saxagliptin Tablets 2.5 mg and 5 mg

USFDA gives tentative nod for these two generic drugs

India’s first Biopharma Hub to be established in Telangana

Himachal gets first installment of Rs 225 cr for Bulk Drug Park

Show cause notices issued to 13 Ultrasound Centres

USFDA approves bleeding disorder therapy

Govt firm on Ban of online sale of medicines

‘Chintan Shivir’ to be held with focus on Drug Quality Regulation and Enforcement

Kerala cracks down on violators of Cosmetic Rules

Drug alert: 67 out of 1348 samples declared as NSQ in January 2023

New DCGI: Rajeev Raghuvanshi appointed head of apex drug regulatory body

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news