Teva Announces the Launch of a Generic Version of ALOXI® in the United States

 Teva Pharmaceuticals Industries Ltd., (NYSE: TEVA) today announced the launch of a generic version of ALOXI^®1 (palonosetron HCI) injection, 0.25 mg/5 mL, in the United States. Palonosetron hydrochloride injection—in a class of medications called 5-HT₃ receptor antagonists—is used in adults to prevent nausea and vomiting that may occur as a result of receiving cancer chemotherapy with a moderate or high risk of causing nausea and vomiting. It is also given to prevent nausea and vomiting up to 24 hours after surgery.

"The shared-exclusive launch of palonosetron HCI injection marks the eleventh injectable launch over the past year for our generics business," said Brendan O’Grady, Executive Vice President and head of North America Commercial at Teva. "More importantly, we can now provide an affordable treatment option for cancer patients faced with challenging post-chemotherapy side effects."

Teva has been committed to strengthening the generic injectable business globally with continued investment in newer, higher-value generic injectable products. With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

ALOXI^® (palonosetron HCI) injection had annual sales of approximately $459 million in the United States, according to IMS data as of November 2017.

About Palonosetron Hydrochloride Injection

Palonosetron hydrochloride injection is indicated in adults for:

• Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses.
• Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses.
• Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.

As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.

Important Safety Information

Palonosetron hydrochloride injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components. Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT₃ receptor antagonists. Serotonin syndrome has been reported with 5-HT₃receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs. Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT₃ receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT₃ receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.

In clinical trials, the most common adverse reactions in chemotherapy-induced nausea and vomiting in adults (incidence ≥ 5%) were headache and constipation. The most common adverse reactions in postoperative nausea and vomiting (incidence ≥ 2%) were QT prolongation, bradycardia, headache, and constipation.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies.