Dr. Reddy's Laboratories Received Approval for Their NDA, ELYXYB (celecoxib oral solution) 25 mg/mL, in the U.S.

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced approval of ELYXYB (celecoxib oral solution 25 mg/mL) by the U.S. Food and Drug Administration (USFDA). ELYXYB (previously known as DFN-15) is indicated for the acute treatment of migraine with or without aura in adults. ELYXYB is the latest product emerging from Dr. Reddy’s portfolio of successful acute migraine treatments. The company is working to commercialize this product through partners.

Erez Israeli, CEO of Dr. Reddy’s Laboratories, commented, “We are excited about the approval of ELYXYB. It reaffirms our commitment to innovation and to develop meaningfully differentiated products that address significant unmet needs of patients and physicians, leading to better health outcomes.”

According to Anil Namboodiripad, PhD, Sr. Vice President of the Proprietary Products Group, Dr. Reddy’s Laboratories, “ELYXYB is an oral solution of celecoxib formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption¹. This allows for administration of a lower dose without affecting bioavailability. In pivotal studies, ELYXYB demonstrated a rapid onset of action which is critically important to patients suffering from acute migraine attacks. The results from pivotal studies with ELYXYB established efficacy of celecoxib in the treatment of migraine with very few adverse events. For patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options. ELYXYB’s oral solution dosage form makes it convenient for patients to take it immediately upon emergence of migraine attacks.”

INDICATION AND USAGE

ELYXYB is indicated in adults for the acute treatment of migraine with or without aura.

Limitations of Use:

• ELYXYB is not indicated for the preventive treatment of migraine.

IMPORTANT SAFETY INFORMATION:

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use [see Warnings and Precautions (5.1)]. ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)]. Gastrointestinal Bleeding, Ulceration, and Perforation