Drug major Dr Reddy’s Laboratories on Monday announced approval from the US health regulator for Xeglyze lotion, used in treatment of head lice infestation. In September 2015, Dr Reddy’s Laboratories had signed a commercialisation deal with Australia’s Hatchtech for the latter’s prescription head lice product Xeglyze Lotion.
Dr Reddy’s Laboratories said it is working to commercialise this product through partners.
In a regulatory filing, Dr Reddy’s Laboratories announced it has received “approval of Xeglyze (abametapir) lotion… by the US Food and Drug Administration (USFDA)”.
The approval triggers the contractual pre-commercialisation milestone of USD 20 million (about Rs 149 crore) payable to Hatchtech Pty Ltd, the company added.
Xeglyze is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.
Earlier, Dr Reddy’s Laboratories announced the launch of over-the-counter Nicotine Polacrilex lozenges in the American market.
The company has launched Nicotine Polacrilex lozenges in the strengths of 2 mg and 4 mg in the US, the pharma major said in a filing to BSE.
The product is a store brand version of GlaxoSmithKline Consumer Healthcare LP’s Nicorette lozenges, it added.
“This launch truly demonstrates our ability to deliver on more complex dosage forms for the benefit of consumers who wish to quit smoking by reducing withdrawal symptoms, including nicotine cravings,” Dr Reddy’s Laboratories North America Generics CEO Marc Kikuchi said.
Nicotine Polacrilex lozenges are an important addition to the company’s current offering of Nicotine Replacement Therapy including Nicotine Transdermal System Patches, sold as Habitrol brand and various store brands, he added.
According to data analytics and market research firm IRI, the Nicotine Lozenges brands and store brand markets had total US retail sales of around USD 200 million for the most recent 52 weeks ended May 17, 2020, Dr Reddy’s said.
