Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to launch its isotretinoin capsules in six different strengths. The approval allows the company to produce generic versions of Absorica, a prescription treatment for severe and hard-to-treat forms of nodular acne. The six strengths, ranging from 10 mg to 40 mg, will enable physicians to choose the most suitable dose for each patient’s individual needs.
The isotretinoin capsules will be manufactured at Zydus’ plant in Moraiya, Ahmedabad, ensuring that the product meets global quality standards. This approval marks a significant milestone for the company, which has now received 427 final approvals from the USFDA. Zydus is competing in the US generics market, which is valued at $64.9 billion and growing.
The company has a total of 492 Abbreviated New Drug Application (ANDA) approvals, including 19 tentative approvals, from the USFDA since it started filing in 2003-04. This approval demonstrates Zydus’ commitment to providing affordable skincare solutions to global markets. The company is expanding its product portfolio in dermatology and other critical therapeutic areas, and expects to continue seeking new global partners to help fulfill its mission to supply high-quality products to meet patient needs.
With this approval, Zydus is well-positioned to tap into the growing demand for generic medications in the US market. The company’s commitment to quality and affordability is likely to benefit patients who are in need of effective treatments for severe acne. As Zydus continues to expand its product portfolio and strengthen its partnerships, it is expected to play a significant role in the global generics market. The company’s focus on dermatology and other critical therapeutic areas is also likely to drive growth and innovation in the healthcare industry.