Latest news with #Absorica
Business Standard
26-05-2025
- Business
- Business Standard
Zydus Life gets USFDA nod for Isotretinoin capsules
Zydus Lifesciences announced that it has received a final approval for Isotretinoin capsules from US Food and Drug Administration (USFDA). The approved drug is the generic equivalent of the reference listed drug Absorica capsules, available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg strengths. Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne. The product will be manufactured at the Groups facility in Moraiya, Ahmedabad. According to IQVIA MAT 2025, Isotretinoin capsules had annual sales of $115.4 million in the United States. As of 31st March 2025, the group now has received a total of 427 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04. Zydus Lifesciences is a global life sciences company engaged in the discovery, development, manufacturing, and marketing of a wide range of healthcare therapies. The companys consolidated net profit fell 1% to Rs 1,170.90 crore despite of 17.2% increase in net sales to Rs 6290.20 crore in Q4 FY25 over Q4 FY24. The counter rose 0.45% to settle at Rs 908 on Friday, 23 May 2025.
Miami Herald
02-04-2025
- Health
- Miami Herald
FDA simplifies rules governing use of popular acne medication isotretinoin
The iPLEDGE program is a risk management system mandated by the U.S. Food and Drug Administration to prevent fetal exposure to isotretinoin, a medication used for severe acne that doesn't respond to other treatments. Accutane was a popular brand name for isotretinoin that is no longer available in the U.S. Other brands of prescription isotretinoin are still used, including Claravis, Absorica, Amnesteem and Zenatane. Due to isotretinoin's high risk of causing birth defects, strict protocols have been established to ensure that patients, especially those who can become pregnant, adhere to safety measures during treatment. However, some of the guidelines outlined in the iPLEDGE program were previously overly strict, confusing and non-inclusive. Finally, the FDA has modified the program's guidelines. Recent modifications to the iPLEDGE program In response to feedback from healthcare professionals and patients, the FDA has made significant changes to the iPLEDGE program to reduce administrative burdens and improve patient access: ▪ Elimination of the 19-day lockout period. Previously, if patients did not obtain their isotretinoin prescription within a seven-day window, they faced a 19-day waiting period before they could requalify for the medication. The recent changes have removed this lockout, allowing patients to resume treatment more promptly. ▪ Acceptance of at-home pregnancy tests. The FDA now permits the use of at-home and non-Clinical Laboratory Improvement Amendments (CLIA) pregnancy tests, reducing the need for in-office visits solely for testing purposes. ▪ Gender-neutral patient classifications. Recognizing the diverse patient population, the program has adopted gender-neutral categories, focusing on patients' reproductive potential rather than gender. Implications for acne patients These modifications should significantly improve the experience for patients taking isotretinoin by reducing treatment delays and thus leading to better treatment outcomes, reducing office visits for the sole purpose of testing and promoting inclusivity. Thus, if you are currently taking isotretinoin or are considering taking this medication, know that these guidelines should make the process much smoother and more streamlined moving forward. Bottom line The iPLEDGE program plays an important role in preventing harmful birth defects that could arise from use if isotretinoin. However, previous guidelines created several barriers for both patients and their doctors when treating and managing severe acne. These new guidelines are more reasonable, while still working to optimize patient safety. I'm still on sabbatical and no longer run Baumann Cosmetic Institute, so please follow @SkinTypeSolutions on social media, or visit if you have questions.
