Tuesday, November 24, 2020
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.

Drug
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)

STAY CONNECTED

19,120FansLike
362FollowersFollow
1,783FollowersFollow

Most Popular

Snapchat Releases Spotlight, To Pay Top Creators

Taking on TikTok, Popular photo-messaging platform Snapchat on Monday officially released Spotlight where Snapchatters will also have the opportunity to earn as they do...

Care For COVID+ Mothers and Newborn Babies

Many COVID-19 positive pregnant women experience mild symptoms of cold or flu. However, pregnant women who are older, overweight, or have pre-existing medical conditions...

MP Govt To Produce Clean Fuel From Stubble Burnt

The Madhya Pradesh government has proposed a plan to set up an industrial unit producing fuel from stubble burnt by the farmers in the...

Felling of 315 Trees When Air Quality is Worse in Delhi

The Delhi High Court on Monday sought a response from the AAP government and others over a petition against an order for felling of...

Cyber Frauds May Increase in India in 2021: Kaspersky

With more users getting connected to the Internet and entering the digital payments ecosystem, cyber fraud incidents may go up in 2021, a researcher...

UP Marks Record in Production And Sales of Sanitizers

The Yogi Adityanath government in Uttar Pradesh has used the 'opportunity in adversity' concept to create a record of sorts in the production and...

Greater Risks of STI in People Above 45

Researchers have found that people above 45s are at a higher risk of contracting sexually transmitted infections (STIs) than ever before because of society's...

SC Happy About Permanent Commission of Women Army Officers

The Supreme Court on Monday expressed happiness after learning that the Centre has implemented its verdict to grant permanent commission to women officers in...

Recent Comments