Dr. Reddy’s Announces the Launch of Zenatane™ (Isotretinoin Capsules USP)
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).
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