Generic Dexamethasone Tablets: USFDA Approval to Zydus for Arthritis

The United States FDA granted approval to Zydus Lifesciences to market generic Dexamethasone tablets 1 mg, in the US, 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 ().

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 ().

Adverse Effects of Rheumatoid Arthritis Medicines on Pregnant Women and Fetus
Certain drugs for rheumatoid arthritis may lead to abortion or stillbirth if used during pregnancy.

‘Approximately 70% of individuals diagnosed with rheumatoid arthritis are women, with 55% being over the age of 55. #arthritis #dexamethasone #USFDAapproval #medindia’

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.

Dexamethasone: Steroid Drug to Treat Allergies, Rheumatic and Skin Diseases
Dexamethasone is a corticosteroid works by preventing the release of a particular substance which is responsible for causing inflammation. It is prescribed for conditions like arthritis, gout, cerebral edema, myelomas, and multiple sclerosis.

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.

What is arthritis?
The pain in the joints can be effectively eased through the practice of yoga, which gives flexibility to the joints and strength to the muscles of the body parts

References:

Zydus Lifesciences Dexamethasone Tablets Bags USFDA Okay - (https://medicaldialogues.in/news/industry/pharma/zydus-lifesciences-dexamethasone-tablets-bags-usfda-okay-128419)
What Is Arthritis? - (https://www.arthritis.org/health-wellness/about-arthritis/understanding-arthritis/what-is-arthritis)

Source-Medindia

Quiz on Arthritis
Do you know that there are more than 100 types of arthritis? If you think that only old people suffer from arthritis, take this intriguing quiz to get your facts on ...