Zydus Receives USFDA Approval for Pitavastatin Tablets to Reduce Cholesterol
Zydus Lifesciences and its affiliates have been granted final approval from the USFDA for Pitavastatin Tablets. The tablets, available in 1 mg, 2 mg, and 4 mg, are indicated as an adjunctive therapy to diet for adult patients with primary hyperlipidemia or mixed dyslipidemia, and for pediatric patients aged 8 years or older with heterozygous familial hypercholesterolemia.
The medication reduces elevated levels of total cholesterol, low-density lipoprotein cholesterol, and triglycerides while increasing high-density lipoprotein cholesterol. Annual sales of Pitavastatin Tablets in the US were USD 319 million as of Dec. 2022, and they will be manufactured at Zydus’ Moraiya facility.
Zydus Continues to Expand its Portfolio with 345 Approvals and Over 440* ANDA Filings
Zydus Lifesciences has received 345 approvals and filed over 440* ANDAs since starting the process in FY 2003-04. The company’s continued commitment to expanding its portfolio and increasing accessibility to affordable healthcare underscores its position as a leading global pharmaceutical manufacturer.
*The exact number of ANDA filings could not be determined.
About Zydus Lifesciences:
In 1995, the group was restructured and thus was formed Cadila Healthcare under the aegis of the Zydus group. From a humble turnover Rs. 250 crores in 1995 the group witnessed a significant financial growth and registered a turnover of over Rs. 14,253 crores in FY20.
Adhering to its brand promise of being dedicated to life in all its dimensions, Zydus continues to innovate with an unswerving focus to address the unmet healthcare needs. Simultaneously it rededicates itself to its mission of creating healthier, happier communities across the globe.
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