Dr. Reddy's Laboratories Announces the Launch of Vigabatrin Tablets, USP in the U.S. Market
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred
to as “Dr. Reddy’s”) today announced the launch of Vigabatrin
Tablets USP, 500 mg, a therapeutic equivalent generic version of
Sabril® (vigabatrin) Tablets, USP, approved by the U.S. Food and
Drug Administration (USFDA).
“We are pleased that this product has been designated as a
Competitive Generic Therapy (CGT) by the FDA,” says Marc Kikuchi,
Chief Executive Officer, North America Generics, Dr. Reddy’s
Laboratories. “With a CGT designation, we have 180-day CGT
exclusivity to market this product.”
The Sabril® brand and generic had U.S. sales of approximately
$141 million MAT for the most recent twelve months ending in
December 2020 according to IMS Health*.
Dr. Reddy’s Vigabatrin Tablets, USP are available in 500 mg
tablets in a bottle count size of 100.
Please see for full prescribing information including boxed
WARNING: PERMANENT VISION
- Vigabatrin can cause permanent bilateral concentric visual
field constriction, including tunnel vision that can result in
disability. In some cases, vigabatrin also can damage the central
retina and may decrease visual acuity [see Warnings and Precautions
- The onset of vision loss from vigabatrin is unpredictable, and
can occur within weeks of starting treatment or sooner, or at any
time after starting treatment, even after months or years.
- Symptoms of vision loss from vigabatrin are unlikely to be
recognized by patients or caregivers before vision loss is severe.
Vision loss of milder severity, while often unrecognized by the
patient or caregiver, can still adversely affect function.
- The risk of vision loss increases with increasing dose and
cumulative exposure, but there is no dose or exposure known to be
free of risk of vision loss.
- Vision assessment is recommended at baseline (no later than 4
weeks after starting vigabatrin), at least every 3 months during
therapy, and about 3 to 6 months after the discontinuation of
- Once detected, vision loss due to vigabatrin is not reversible.
It is expected that, even with frequent monitoring, some patients
will develop severe vision loss.
- Consider drug discontinuation, balancing benefit and risk, if
vision loss is documented.
- Risk of new or worsening vision loss continues as long as
vigabatrin is used. It is possible that vision loss can worsen
despite discontinuation of vigabatrin tablets.
- Because of the risk of vision loss, vigabatrin should be
withdrawn from patients with refractory complex partial seizures
who fail to show substantial clinical benefit within 3 months of
initiation and within 2 to 4 weeks of initiation for patients with
infantile spasms, or sooner if treatment failure becomes obvious.
Patient response to and continued need for vigabatrin should be
- Vigabatrin should not be used in patients with, or at high risk
of, other types of irreversible vision loss unless the benefits of
treatment clearly outweigh the risks.
- Vigabatrin should not be used with other drugs associated with
serious adverse ophthalmic effects such as retinopathy or glaucoma
unless the benefits clearly outweigh the risks.
- Use the lowest dosage and shortest exposure to vigabatrin
consistent with clinical objectives [see Dosage and Administration
Because of the risk of permanent vision
loss, vigabatrin tablets are available only through a restricted
program under a Risk Evaluation and Mitigation Strategy (REMS)
called the Vigabatrin REMS Program [see Warnings and Precautions
(5.2)]. Further information is available at www.vigabatrinREMS.com
Sabril® is a trademark of Lundbeck. *IMS National Sales
Perspective: Retail and Non-Retail MAT December 2020
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. ((BSE:
500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) 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:
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on
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unknown risks and uncertainties that could cause actual results,
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including related integration issues , and (vi) the susceptibility of our industry
and the markets addressed by our, and our customers’, products and
services to economic downturns as a result of natural disasters,
epidemics, pandemics or other widespread illness, including
coronavirus (or COVID-19), and (vii) other risks and uncertainties
identified in our public filings with the Securities and Exchange
Commission, including those listed under the "Risk Factors" and
"Forward-Looking Statements" sections of our Annual Report on Form
20-F for the year ended March 31, 2020. The company assumes no
obligation to update any information contained herein.”
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