Market Overview

Cycle Pharmaceuticals Receives FDA Approval for Ketorolac Tromethamine Tablets in the U.S.


Cycle Pharmaceuticals Ltd ("Cycle") is pleased to announce that it has
received approval from the U.S. Food and Drug Administration ("FDA") of
its Abbreviated New Drug Application ("ANDA") for Ketorolac Tromethamine
Tablets 10mg. Ketorolac Tromethamine Tablets, a nonsteroidal
anti-inflammatory drug ("NSAID"), are indicated for the short-term (up
to 5 days in adults), management of moderately severe acute pain that
requires analgesia at the opioid level and only as continuation
treatment following intravenous ("IV") or intramuscular ("IM") dosing of
ketorolac tromethamine, if necessary.

"After the successful launch of Ketorolac Tromethamine IV last year,
we are proud to be announcing the second product approval from our
Generics Division"
said Brian Sergenian, North America
Director, Cycle.

"We are pleased to be expanding consistently our portfolio in line
with our launch targets. With this approval we continue the expansion of
our business with a special focus on the US market"
said Antonio
, CEO, Cycle.

For full prescribing information, including Boxed Warning, please

About Cycle Pharmaceuticals Ltd.

Cycle is a pharmaceutical company that optimizes and increases access to
existing pharmaceuticals. Specifically, Cycle focuses on three areas of
pharmaceutical development:

- Improving orphan drugs, which treat the under-served rare disease
patient community;

- Reinstating generic drug products that have been previously marketed;

- Working with our academic and other partners to extend pharmaceuticals
to new medical areas where there is clear unmet need. The company's
global headquarters is in Cambridge, England. For further information,
please visit

View Comments and Join the Discussion!