Friday, May 7, 2021
Home Life Style Health & Fitness FDA Grants Orphan Drug Designation to Lupin's Drug Mexiletine Hydrochloride

FDA Grants Orphan Drug Designation to Lupin’s Drug Mexiletine Hydrochloride

Pharma major Lupin' drug, mexiletine hydrochloride got granted Orphan Drug Designation (ODD) by FDA for the treatment of myotonic disorders

Pharma major Lupin on Monday said the US health regulator Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its drug mexiletine hydrochloride for the treatment of myotonic disorders. The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 2 lakh people in the US.

“The decision by the US FDA to grant orphan drug designation to mexiletine brings us closer to providing a licensed treatment option for patients in the US,” Vinita Gupta, CEO, Lupin Limited, said in a statement.

Myotonic disorders are a group of neuromuscular disorders characterized by a shared symptom called myotonia which is an inability to relax a contraction of skeletal muscle which originates from a voluntary muscular contraction such as shaking someone’s hand and blinking, or everyday activities such as walking across a street and climbing stairs.

FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 2 lakh people in the US. Pixabay

Mumbai-based Lupin’s drug NaMuscula (mexiletine hydrochloride) is the only licensed product to treat myotonia in adults with non-dystrophic myotonic (NDM) disorders. “We are pleased to have this opportunity to further our commitment to these patients,” Gupta added. In April, the company had received an Establishment Inspection Report (EIR) from US FDA for its manufacturing plant in Nagpur.

Follow Newsgram on Facebook for more updates 

Lupin is the third-largest pharmaceutical company in the US by prescriptions and in India by global revenues. The company invests 9.6 per cent of its revenues on research and development.

Also Read: This New ‘Ensilication’ Method Allows Childhood Vaccines To be Kept Safe In All Temperatures

It has 15 manufacturing sites and seven research centres, with more than 20,000 professionals working globally. (IANS)



Most Popular

Google Planning To Give Users More Controls About How Their Data Is Used By Apps

After Apple gave users more control over their data sharing with app developers, Google has now pre-announced an upcoming safety section in Google Play...

Lancet: COVID Pneumonia Puts 1 In Every 3 Women At Lung Damage Risk

Most patients hospitalized for Covid-19 infection return to full health, but one in three may develop lung damage even after a year, according to...

Report: Immediate Action Is Needed To Reduce Methane Emissions

A Global Methane Assessment released on Thursday by the Climate and Clean Air Coalition (CCAC) and the United Nations Environment Programme (UNEP) showed that...

Racism In The United States Has a Long History

By- Khushi Bisht It was 1915, and India was still fighting for freedom when a man with his wife and three children chose to flee...

The Global Social And Economic Impact Of The Gambling Industry

By Rahul Rana Gambling as a form of leisure has been around since the dawn of modern civilization. It has undergone many different evolutions and...

7 Tips To Prevent Dark Spots From Body

If you are someone prone to pigmentation, then you might know the struggle of getting rid of dark spots. Recurring and stubborn dark spots...

Exploring The World’s Greatest Investors Minds

Billionaire investors. If we think of them, it's with a mixture of awe and suspicion. Clearly, they possess a kind of genius -- the...

Sumptuous Iftar’s Recipes For Evening

While many spend the holy month Ramadan fasting, part of the rituals include breaking the daily fast with an evening meal. The Park Hotels...

Recent Comments