USFDA Approval to Zydus for Arthritis


Generic Dexamethasone Tablets: USFDA Approval to Zydus for Arthritis

Zydus Lifesciences, an Indian pharmaceutical company, revealed on Saturday that it has obtained the final approval from the US Food and Drug Administration (USFDA) to distribute a generic drug for arthritis and various other medical conditions, in the US. This approval is for Dexamethasone Tablets USP, 1 mg (1✔ ✔Trusted Source
Zydus Lifesciences Dexamethasone Tablets Bags USFDA Okay

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).
Arthritis is not a single disease but a range of joint pain conditions, with over 100 types falling under this umbrella term. It affects people of all ages, races, and genders and is the leading cause of disability in the US. Although it primarily affects women and older individuals, it is not exclusively associated with aging (2✔ ✔Trusted Source
What Is Arthritis?

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).

Dexamethasone is prescribed for the treatment of various conditions including arthritis, blood/hormone disorders, allergic reactions, eye problems, skin diseases, bowel disorders, breathing problems, cancer, and immune system disorders.

The company announced that the product will be produced at the group’s formulation manufacturing plant in Baddi, Himachal Pradesh.

The annual sales of Dexamethasone Tablets in the United States were $1.8 million, as per the information provided by IQVIA, a leading global provider of advanced analytics and technology solutions.

Zydus Lifesciences obtained the final approval from the USFDA to distribute Dapsone Gel, 7.5 percent, earlier this week. Dapsone Gel is prescribed for the treatment of acne and will be produced at the company’s topical manufacturing plant located in Changodar, Ahmedabad, Gujarat.

The company stated that since the inception of the filing process in FY 2003-04, they have filed over 460 Abbreviated New Drug Applications (ANDAs) and obtained 395 approvals as of December of the previous year.

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References:

  1. Zydus Lifesciences Dexamethasone Tablets Bags USFDA Okay – (https://medicaldialogues.in/news/industry/pharma/zydus-lifesciences-dexamethasone-tablets-bags-usfda-okay-128419)

  2. What Is Arthritis? – (https://www.arthritis.org/health-wellness/about-arthritis/understanding-arthritis/what-is-arthritis)

Source-Medindia





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