Dr. Reddy’s announces the launch of Zenatane™ (Isotretinoin Capsules USP)
Hyderabad, India, March 29, 2013
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Zenatane™ (Isotretinoin Capsules USP) in 20 mg and 40 mg, a therapeutically equivalent generic version of Accutane® (Isotretinoin Capsules USP) in the US market on March 28, 2013 following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Zenatane™ 10 mg, 20 mg and 40 mg.
The total market had U.S. sales of approximately $309 Million for the most recent twelve months ending January 2013 according to IMS Health*.
Dr. Reddy’s Zenatane™ Capsules 10 mg, 20 mg, & 40 mg will be available in boxes of 30 (3 prescription packs of 10 capsules), as unit dose blisters.
CONTRAINDICATIONS AND WARNINGS
Zenatane™ must not be used by female 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™ 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. Isotretinoin capsules 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™ (see PRECAUTIONS).
This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, log on to:
Zenatane™ is a trademark of Dr. Reddy’s Laboratories and or its affiliates.
Accutane® is a trademark of Hoffman- La Roche Inc.
iPLEDGE™ is a trademark of Covance, Inc
*IMS National Sales Perspectives: Retail and Non-Retail MAT January 2013
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