Dr. Reddy's Laboratories announces the re-launch of Zenatane® in the U.S. Market
- Post By : Kumar Jeetendra
- Source: MBI
- Date: 03 June, 2019
Hyderabad, India and Princeton, NJ, USA. June 3, 2019 — Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the re-launch of Zenatane® (Isotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg and 40 mg a therapeutic equivalent generic version of Accutane®, approved by the U.S. Food and Drug Administration (USFDA). The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Program.
“We’re pleased to bring this important product back to market for the customers and patients who will benefit from access to this medicine and who have had witnessed limited supply and options in the market place,” explains Marc Kikuchi, Chief Executive Officer, North America Generics. “Furthermore, this is important for our company as we have commercialized the first Softgel dosage product from Dr. Reddy’s own manufacturing plant to ensure consistent and robust supply for this product in the U.S. market.”
The Zenatane (Isotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg and 40 mg brand and generic had U.S. sales of approximately $525 million MAT for the most recent twelve months ending in March 2019 according to IQVIA Health*.
Dr. Reddy’s Zenatane (Isotretinoin Capsules, USP) are available in 3x10 (30-count) blister packages of 10 mg, 20 mg 30 mg, and 40 mg Capsules, USP
Contraindications and warnings
Zenatane must not be used by patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Zenatane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
Birth defects which have been documented following Zenatane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.
Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.
If pregnancy does occur during treatment of a female patient who is taking Zenatane, Zenatane must be discontinued immediately and she should be referred to an Obstetrician- Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Special Prescribing Requirements
Because of Zenatane’s teratogenicity and to minimize fetal exposure, Zenatane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Zenatane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Zenatane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE.