Amneal gains FDA nod for launch of Revatio® & Amicar® tablets
Category: #health  By Mateen Dalal  Date: 2019-12-04
  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn

Amneal gains FDA nod for launch of Revatio® & Amicar® tablets

Amneal Pharmaceuticals, Inc. has made some consistent ripples in the generics and specialty pharmaceutical industry. Recently, the company made headlines when it revealed attaining final approval from the U.S. FDA on its ANDA (Abbreviated New Drug Applications) for generic editions of Amicar® (aminocaproic acid) Tablets USP, 500 mg and Revatio® for Oral Suspension 10 mg/ml.

According to a statement, Chintu Patel, Co-CEO, Amneal, said that their company is delighted to introduce these new drugs to healthcare providers and patients. He claims that their firm’s diverse and large pipeline has managed to deliver 36 new generic items in 2019 across multiple dosage forms.

Reportedly, Amneal had earlier bagged the designation of Competitive Generic Therapy (CGT) from the FDA for the generic version of Amicar®. Considering its first approved application, the biotech has been offered 180 days of CGT exclusivity.

Prior to this news, Amneal was in limelight for the launch of the generic version of Invega® (paliperidone). The drug was introduced in extended-release tablets ranging from 1.5mg to 9mg.

Speaking of which, Patel said that the company is pleased to get an approval for the launch of the generic version of Invega. It marks as one of 15 complex drugs that the firm expects to launch over 24-month.

Moreover, with a varied lineup of over 170 products, the company hopes to progress these types of complex product approvals, which would further expand its portfolio. Also, such moves would allow patients to buy generic medicines at affordable prices, cites Patel.

For the record, Amneal Pharmaceuticals, Inc. is based in Bridgewater, New Jersey. It is an integrated pharmaceutical firm focused on manufacturing, developing and distributing branded, generic, and biosimilar products. Amneal has operations in Asia, North America and Europe, and is working on bringing high-quality medicines to patients primarily within the U.S.
 

Source Credit: https://investors.amneal.com/news/press-releases/press-release-details/2019/Amneal-Announces-the-Approval-and-Launch-of-Generic-Revatio-for-Oral-Suspension-and-Generic-Amicar-Tablets/default.aspx

  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal     twitter

Mateen Dalal

A qualified electronics and telecommunication engineer, Mateen Dalal embarked on his professional journey working as a quality and test engineer. Harnessing his passion for content creation however, Mateen pens down industry-rich articles for ReportsGO.com and a few o...

Read More..

More News By Mateen Dalal

Facebook testing new option for cross-posting content to Instagram

Facebook testing new option for cross-posting content to Instagram

By Mateen Dalal

Facebook, Inc is reportedly testing an option that will allow users to cross-post their photos, videos, and other posts on their Instagram. It already has the feature to let people cross-post their Instagram content to Facebook. This upcoming featur...

General Motors to recoup USD 1.9 Bn from LG spent on Bolt EV recall

General Motors to recoup USD 1.9 Bn from LG spent on Bolt EV recall

By Mateen Dalal

GM will recover almost all the costs from the recall of its Bolt EV models. Despite the EV battery manufacturing mishap from LG, the two companies will continue to work together. General Motors (GM) has agreed to recover around USD 1.9 billion f...

Tata Motors records 25% jump in global sales in second quarter of 2021

Tata Motors records 25% jump in global sales in second quarter of 2021

By Mateen Dalal

The automaker’s annual wholesale growth has been around 24%. The company saw a 10% rise in passenger car sales during Q2 2021, as compared to the same period in 2020. Tata Motors Limited reported substantial growth in Q2 2021, with its glo...