Zydus Lifesciences gets USFDA nod to market colestipol hydrochloride tablets
The approval by the US Food and Drug Administration is for colestipol hydrochloride of 1 mg strength, the company said in a regulatory filing.
New Delhi: Zydus Lifesciences Ltd on Monday said it has received the final approval from the US health regulator to market its generic version of colestipol hydrochloride tablets, which is used to lower cholesterol. The approval by the US Food and Drug Administration is for colestipol hydrochloride of 1 mg strength, the company said in a regulatory filing.
Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C (low-density lipoprotein, known as bad cholesterol) in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet, it added.
"Zydus' ANDA is only the second generic application approved by USFDA for this product," it said.
The drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad, the company added.
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Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.
Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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