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JERUSALEM--(BUSINESS WIRE)--Aug. 6, 2018--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced
today that the U.S. Food and Drug Administration (FDA) has approved
GRANIX® (tbo-filgrastim) Injection for a new vial
presentation and indication in pediatric patients 1 month and older.
GRANIX is indicated to reduce the duration of severe neutropenia in
adult and pediatric patients 1 month and older with nonmyeloid
malignancies receiving myelosuppressive anticancer drugs associated with
a clinically significant incidence of febrile neutropenia.
The new vial presentation of the product will be available for use in
300mcg/1mL and 480mcg/1.6mL single-dose vials. The prefilled syringe
presentations will continue to be available as well.
“The new pediatric indication and vial presentation of GRANIX expand the
range of treatment options that can be of benefit to both patients and
healthcare providers,” said Brendan O’Grady, EVP and Head of North
America Commercial at Teva.
GRANIX was approved by the FDA in August 2012. GRANIX vials are expected
to be available in the U.S. shortly.
Important Safety Information
Please see Full Prescribing Information for GRANIX here.
About TevaTeva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a global leader in generic medicines, with innovative
treatments in select areas, including CNS, pain and respiratory. We
deliver high-quality generic products and medicines in nearly every
therapeutic area to address unmet patient needs. We have an established
presence in generics, specialty, OTC and API, building on more than a
century-old legacy, with a fully integrated R&D function, strong
operational base and global infrastructure and scale. We strive to act
in a socially and environmentally responsible way. Headquartered
in Israel, with production and research facilities around the globe, we
employ 45,000 professionals, committed to improving the lives of
millions of patients. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch and potential benefits of GRANIX®,
which are based on management’s current beliefs and expectations and are
subject to substantial risks and uncertainties, both known and unknown,
that could cause our future results, performance or achievements to
differ significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
and other factors discussed in our Annual Report on Form 10-K for the
year ended December 31, 2017, including the sections thereof captioned
"Risk Factors" and "Forward Looking Statements," and in our subsequent
quarterly reports on Form 10-Q and other filings with the Securities and
Exchange Commission, which are available at www.sec.gov
Forward-looking statements speak only as of the date on which they are
made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise. You
are cautioned not to put undue reliance on these forward-looking
View source version on businesswire.com: https://www.businesswire.com/news/home/20180806005263/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.IR ContactsUnited StatesKevin
C. Mannix, 215-591-8912orRan Meir, 972 (3) 926-7516orPR
ContactsUnited StatesDoris Saltkill, 913-777-3343orIsraelYonatan
Beker, 972 (54) 888 5898