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Dr. Reddy’s Laboratories Announces the Re-Launch of Zenatane® (Isotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg and 40 mg in the U.S. Market

June 3, 2019 Off By BusinessWire

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.

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.

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
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“plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential,” or “continue” and similar expressions identify
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(ii) mortality and morbidity levels and trends, (iii) changing levels of
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regulations and in the policies of central banks and/or governments, (v)
the impact of acquisitions or reorganization, including related
integration issues.