Lupin Secures US FDA Approval for Diazepam Rectal Gel

Lupin gets tentative US FDA nod for apalutamide tablets

Lupin Limited, a leading pharmaceutical company, made an exciting announcement on Thursday regarding its subsidiary, Novel Laboratories Inc. The United States Food and Drug Administration (US FDA) has granted approval for Diazepam Rectal Gel, an important medication used in emergency situations to control cluster seizures in individuals who are already receiving treatment for epilepsy.

In a regulatory filing with the exchanges, Lupin stated, “We are pleased to announce that our wholly-owned subsidiary, Novel Laboratories Inc., based in Somerset, New Jersey, has received approval from the US FDA for its Abbreviated New Drug Application for Diazepam Rectal Gel. This rectal delivery system is available in 10 mg and 20 mg strengths and serves as a generic equivalent to Diastat AcuDial Rectal Delivery System, which is marketed by Bausch Health US, LLC.”

According to market data from IQVIA as of March 2023, the sales of Diazepam Rectal Gel (known as RLD Diastat AcuDial) in the United States were estimated to reach $34 million annually.

Just a day earlier, on May 31, Lupin had also disclosed its US FDA approval for the Abbreviated New Drug Application of Obeticholic Acid Tablets, available in 5 mg and 10 mg strengths. This generic alternative corresponds to Intercept Pharmaceuticals, Inc.’s Ocaliva Tablets. The manufacturing of this product will take place at Lupin’s facility in Nagpur, India.

On the stock market, Lupin’s shares were observed trading 1.02 percent higher at Rs 812.70 per share as of 2:53 pm on the NSE.

About Lupin:

Lupin Limited, headquartered in Mumbai, is an Indian multinational pharmaceutical company. It holds a prominent position among the leading global generic pharmaceutical companies in terms of revenue. Lupin’s primary areas of specialization encompass pediatrics, cardiovascular medicine, anti-infectives, diabetology, asthma treatments, and anti-tuberculosis drugs.

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