HQ Team
February 20, 2023: Zydus Lifesciences, a subsidiary of Zydus Pharmaceuticals US, has received two tentative FDA approvals, one for treating type 2 diabetes and the other for shingles.
Canagliflozin and metformin hydrochloride combination tablets are used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The combination treats patients who are not adequately controlled on a regimen containing metformin or canagliflozin or in patients but already being treated with both canagliflozin and metformin.
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya in the western state of Gujarat.
The combination tablets had annual sales of $49.4 million in the US, according to research firm IQVIA. The Zydus group now has 344 approvals and has filed over 440 ANDAs.
The FDA also approved Gabapentin tablets to manage post-herpetic neuralgia (PHN). The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya.
Post-herpetic neuralgia is a lasting pain in the areas of the skin where one has shingles. Around one in five people with shingles will get post-herpetic neuralgia.
People at age 50 and over are particularly at risk. Many people with post-herpetic neuralgia make a full recovery within a year.
Gabapentin Tablets had annual sales of $90 million in the US as on December 2022, according to IQVIA research firm.
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