HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–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 3×10
(30-count) blister packages of 10 mg, 20 mg 30 mg, and 40 mg Capsules,
USP.
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CONTRAINDICATIONS AND WARNINGS |
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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. |
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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. |
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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. |
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If pregnancy does occur during treatment of a female patient who |
| Special Prescribing Requirements |
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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. |
Accutane® is a trademark of Hoffman LaRoche
*IQVIA Retail and Non-Retail MAT March 2019
RDY-0519-247
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124)
(NSE: DRREDDY) (NYSE: RDY) is an integrated pharmaceutical company,
committed to providing affordable and innovative medicines for healthier
lives. Through its three businesses – Pharmaceutical Services & Active
Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s
offers a portfolio of products and services including APIs, custom
pharmaceutical services, generics, biosimilars and differentiated
formulations. Our major therapeutic areas of focus are gastrointestinal,
cardiovascular, diabetology, oncology, pain management and dermatology.
Dr. Reddy’s operates in markets across the globe. Our major markets
include – USA, India, Russia & CIS countries, and Europe. For more
information, log on to: www.drreddys.com.
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on the
management’s current views and assumptions and involve known or unknown
risks and uncertainties that could cause actual results, performance or
events to differ materially from those expressed or implied in such
statements. In addition to statements which are forward-looking by
reason of context, the words “may,” “will,” “should,” “expects,”
“plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential,” or “continue” and similar expressions identify
forward-looking statements. Actual results, performance or events may
differ materially from those in such statements due to without
limitation, (i) general economic conditions such as performance of
financial markets, credit defaults, currency exchange rates, interest
rates, persistency levels and frequency/severity of insured loss events,
(ii) mortality and morbidity levels and trends, (iii) changing levels of
competition and general competitive factors, (iv) changes in laws and
regulations and in the policies of central banks and/or governments, (v)
the impact of acquisitions or reorganization, including related
integration issues.
The company assumes no obligation to update any information contained
herein.
Contacts
INVESTOR RELATIONS
AMIT AGARWAL
amita@drreddys.com
(PH:
+91-40-49002135)
MEDIA RELATIONS
MITALI SARKAR
mitali.sarkar@drreddys.com
(PH:
+91-40-49002121)