article thumbnail

Zydus receives final USFDA approval for Eluxadoline Tablets, 75 mg and 100 mg

Express Pharma

The group now has 419 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04. (*As Eluxadoline tablets had annual sales of USD 243.7 mn in the United States (IQVIA MAT January 2025). As of December 31, 2024.)

66
article thumbnail

Episode 979: Does aspiration pneumonia require different antibiotics than community acquired pneumonia?

Pharmacy Joe

Another study from 2003 looked at 95 institutionalized elderly patients with severe aspiration pneumonia. One of these studies was in 1999 by Paul Marik. 143 pneumonia patients were thoroughly cultured using bronchial-alveolar lavage. Out of the 67 pathogens identified, anaerobic bacteria comprised only 16%.

Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015.

article thumbnail

What is the Pharma Marketing Network?

Pharma Marketing Network

Why the Network Matters in Today’s Pharma Landscape Conclusion and FAQs The Mission and History of Pharma Marketing Network Founded in 2003, the Pharma Marketing Network (PMN) was established to meet a growing need for collaboration and knowledge sharing in the evolving world of pharmaceutical communications.

article thumbnail

Pharmacies Need Strategies to Improve Health Care Access

Pharmacy Times

J Am Pharm Assoc (2003). Am J Health Syst Pharm. 2019;76(4):251-253. doi:10.1093/ajhp/zxy040 13. Foster AA, Daly CJ, Logan T, et al. Implementation and evaluation of social determinants of health practice models within community pharmacy. 2022;62(4):1407-1416.doi:10.1016/j.japh.2022.02.005 doi:10.1016/j.japh.2022.02.005

article thumbnail

Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. As of January 1, 2023, CMS has begun issuing unique J-codes to 505(b)(2) drugs dating back to 2003. “In However, 505(b)(2) drugs have been available since the 1980s. “CMS

article thumbnail

GlobalData tracks 40 yrs of innovation in USFDA review designations

Express Pharma

Furthermore, this period also coincided with the advent of the biotech industry, whereby the 2003 completion of the human genome project catalysed gene therapy developments. The period between 2012 and 2020 saw another rapid increase in the annual numbers of review designations awarded.