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Hikma launches Diazepam Injection, USP in the US London, UK, 8 July 2026 – Hikma Pharmaceuticals PLC (Hikma, Group), a multinational pharmaceutical company, today announced the launch of Diazepam Injection, USP, C-IV, 5 mg/mL (10 mg/2 mL), in 2 mL multi-dose vials, supplied in packs of 25, in the US. “We are pleased to expand our injectable portfolio with the launch of Diazepam Injection, USP 10mg/2 mL multi-dose vial in the US following the launch of Diazepam Injection USP 50 mg/10 mL multidose vial in 2023,” said Jon Kafer, Vice President of Commercial for US Injectables. “This addition reflects our commitment to providing clinicians and patients with a comprehensive range of dosage options, ensuring reliable and convenient access to high-quality, affordable medicines across a range of care settings.” Diazepam Injection, USP is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety; as an adjunct in the symptomatic relief of acute agitation, tremor, and delirium tremens in acute alcohol withdrawal; as an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present; as an adjunct for the relief of skeletal muscle spasm; as a useful adjunct in status epilepticus; and as a premedication for relief of anxiety and tension in patients undergoing surgical procedures or cardioversion. Please see the full package insert for boxed warning and other important safety information. According to IQVIA, the total US market for Diazepam Injection was approximately $77 million and 4.1 million units for the full year 2025. - ENDS – This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, 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 9,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, 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 Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB/stable S&P and BBB/stable Fitch) Download full press release Enquiries Hikma Pharmaceuticals PLC Susan Ringdal EVP, Strategic Planning and Global Affairs +44 (0)20 7399 2760/ +44 7776 477050 Steven Weiss US Communications +1 732 788 8279 Important Safety Information for Diazepam Injection, USP, C-IV WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS CONTRAINDICATIONS Diazepam is contraindicated in patients with a known hypersensitivity to this drug; acute narrow angle glaucoma; and open angle glaucoma unless patients are receiving appropriate therapy. WARNINGS & PRECAUTIONS ADVERSE REACTIONS Side effects most commonly reported were drowsiness, fatigue and ataxia; venous thrombosis and phlebitis at the site of injection. Other adverse reactions less frequently reported include: CNS: confusion, depression [including respiratory depression], dysarthria, headache, hypoactivity, slurred speech, syncope, tremor, vertigo. G.I.: constipation, nausea. G.U.: incontinence, changes in libido, urinary retention. Cardiovascular: bradycardia, cardiovascular collapse, hypotension. EENT: blurred vision, diplopia, nystagmus. Skin: urticaria, skin rash. Other: hiccups, changes in salivation, neutropenia, jaundice. Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported; should these occur, use of the drug should be discontinued. Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during and after diazepam therapy and are of no known significance. In peroral endoscopic procedures, coughing, depressed respiration, dyspnea, hyperventilation, laryngospasm and pain in throat or chest have been reported. Because of isolated reports of neutropenia and jaundice, periodic blood counts and liver function tests are advisable during long-term therapy. DRUG INTERACTIONS The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mμ receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. If diazepam is to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed - particularly with known compounds which may potentiate the action of diazepam, such as phenothiazines, narcotics, barbiturates, MAO inhibitors and other antidepressants. In highly anxious patients with evidence of accompanying depression, particularly those who may have suicidal tendencies, protective measures may be necessary. Diazepam injection has produced hypotension or muscular weakness in some patients particularly when used with narcotics, barbiturates or alcohol. The clearance of diazepam and certain other benzodiazepines can be delayed in association with cimetidine administration. The clinical significance of this is unclear. USE IN SPECIFIC POPULATIONS Pediatric Use Efficacy and safety of parenteral diazepam has not been established in the neonate (30 days or less of age). Prolonged central nervous system depression has been observed in neonates, apparently due to inability to biotransform diazepam into inactive metabolites. Benzyl alcohol has been reported to be associated with a fatal gasping syndrome in premature infants. Pregnancy Advise pregnant females that use of diazepam late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation. Monitor neonates exposed to Diazepam injection during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to Diazepam injection during pregnancy for signs of withdrawal; manage these neonates accordingly. Instruct patients to inform their healthcare provider if they are pregnant. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to diazepam during pregnancy. Nursing Advise patients that breastfeeding is not recommended during treatment with diazepam. Diazepam is present in breastmilk. There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. However, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Diazepam injection and any potential adverse effects on the breastfed infant from Diazepam injection or from the underlying maternal condition. OVERDOSAGE Overdosage is characterized by CNS depression ranging from drowsiness to coma. Manage with general supportive measures including intravenous fluids and airway maintenance. Flumazenil may be used adjunctively to, not a substitute for, supportive management of benzodiazepine overdose. Flumazenil can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long term benzodiazepine use and physical dependency. The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients given benzodiazepines for control of a potentially life-threatening condition (e.g., status epilepticus). See the flumazenil injection Prescribing Information. Consider contacting a poison center (1-800-222-1222), poisoncontrol.org or a medical toxicologist for additional overdosage management recommendations. INDICATIONS AND USAGE Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient’s recall of the procedures. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam injection is a useful adjunct in status epilepticus. Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient’s recall of the procedure. ENDING INFORMATION For additional information, please refer to the Package Insert for full prescribing information, available on www.hikma.com. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 USA © 2026. Hikma Pharmaceuticals USA Inc. All rights reserved. HK-3574-v1