article thumbnail

FDA approves Analog and Dipharma’s ANDA for nitisinone capsules

Pharmaceutical Technology

Dipharma is a pioneer in developing improved generic pharmaceutical products for rare diseases: our desire to innovate and our engagement do not stop, but every day we continue to seek new and better solutions for patients around the world.”

article thumbnail

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

The FDA regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as MDIs, that consist of a drug and a device.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

The Pharma Data

The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL. 2,3 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL.

article thumbnail

Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

The Pharma Data

The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL. 1 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL. About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars.

article thumbnail

Novartis’ Sandoz Launches Biosimilars Awareness Campaign to Improve Biosimilars Adoption Worldwide

XTalks

Sandoz is a pioneering leader in generic pharmaceuticals and biosimilars, as Sandoz launched the world’s first biosimilar in Europe in 2006 and won the first biosimilar approval in the US in 2014. Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar.

article thumbnail

Excellence Awards 2022 – Winners Announced!

Pharmaceutical Technology

Sanofi wins the Product Launches award this year following the further development of its Dupixent (dupilumab) product and a string of approvals. In May the drug became the first medicine available in the US for eosinophilic oesophagitis following approval.

Insulin 130
article thumbnail

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 85