LONDON, May 1, 2019 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's / BB+ S&P, both stable) the multinational pharmaceutical company, today launched its 100th injectable medicine in the United States with the introduction of Vancomycin Hydrochloride for
"Vancomycin Hydrochloride for Injection is an essential antibiotic used by hospitals to treat patients who have failed to respond to a number of other antibiotics, and it's another important addition to our growing US portfolio," said Dan Motto, Executive Vice President, Commercial and Development, Injectables. "This launch marks a great milestone – Hikma's 100th injectable medicine in the US – and it demonstrates our commitment to providing doctors and hospitals with a broad range of high-quality medicines needed to treat the current and future needs of patients."
Hikma's Vancomycin Hydrochloride for Injection, USP is indicated for:
and has been:
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to Vancomycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
The parenteral form of Vancomycin Hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of Vancomycin Hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infection.
According to IQVIA, US sales of Vancomycin Hydrochloride for Injection, USP, 5g, 10g and 750mg were approximately $247 million in the 12 months ending February 2019.
"Our portfolio of 100 injectable medicines now covers many vital, large and growing therapeutic areas including oncology, anti-infectives, anaesthesia and pain management," continued Mr. Motto. "We are expecting to launch 15 additional products this year, further strengthening Hikma's position as a top manufacturer and supplier in the US generic injectable market with a strong portfolio that can't easily be replicated."
"Our customers prefer to work with manufacturers that have a large product portfolio and a long record of successful FDA inspections," said Riad Mechlaoui, Hikma's President of Injectables. "Over the years Hikma has established a strong reputation for quality products and reliability. We have made significant investments to build flexible manufacturing capabilities allowing us to shift capacity to where it is needed most, and enabling us to quickly address changing market demands, including US drug shortage situations as they arise."
Hikma is the third largest US supplier of generic injectable medicines by volume, with a growing portfolio of 100 products. Today one in every six injectable generic medicines used in US hospitals is a Hikma product.
Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we're a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner in the MENA region, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit www.hikma.com
Important Safety Information for Vancomycin Hydrochloride for Injection, USP, 5g, 10g, and 750mg:
WARNINGS AND PRECAUTIONS
The following warnings and precautions should be taken when administering Vancomycin Hydrochloride for Injection, USP:
Vancomycin Hydrochloride for Injection is contraindicated in patients with known hypersensitivity to this antibiotic.
The following adverse reactions have been reported: anaphylactoid reactions, flushing of the upper body, acute kidney injury, pseudomembranous colitis symptoms, hearing loss, vertigo, reversible neutropenia, inflammation at the injection site, drug fever, nausea, chills, rashes, and vasculitis. Chemical peritonitis has been reported following intraperitoneal administration.
Postmarketing reports include skin and subcutaneous tissue disorders, drug rash with eosinophilia and systemic symptoms (DRESS).
Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased Vancomycin clearance. To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center.
For additional information, please refer to the Package Insert for the vial and the Package Insert for the pharmacy bulk pack for full prescribing information, available on www.hikma.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL) S.A.Estrada do Rio da Mó nos.8, A/B2705-906 Terrugem SNTPortugal
Distributed by:WEST-WARD A HIKMA COMPANYEatontown, NJ 07724 USA
Document Identification Number: WW30336
1 Hikma Pharmaceuticals USA Inc. was formerly known as West-Ward Pharmaceuticals Corp.
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