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
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
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).
Disclaimer 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: www.drreddys.com
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
Dr. Reddy’s Laboratories
Investors and Financial Analysts:
Kedar Upadhye, +91-40-66834297
Saunak Savla, +91-40-49002135
Milan Kalawadia (USA), +1 908-203-4931
S Rajan, +91-40- 49002445
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