Tag: FDA
Pharmacy Urges US FDA To Disallow Levels Of DMF Solvent It Found In Valsartan
| PharmaIntelligence

The saga of tainted valsartan has taken another turn with an online pharmacy that tests its medications before dispensing them finding yet another probable carcinogen in lots of the blood pressure medication from multiple manufacturers. The pharmacy filed a citizen petition asking the US FDA to tighten its globally harmonized limit for the residual solvent.

Pharmacy takes FDA to task in citizen petition over tainted valsartan
| FiercePharma

The FDA has tied the contamination of blood pressure drugs by probable carcinogens to an approved switch in manufacturing to a process that uses certain solvents. Now an online pharmacy says it has discovered the solvents are as bad as the impurities they have been creating and has criticized the FDA for not taking steps […]

Catalyst Pharma (CPRX) Rides on Successful Launch of Firdapse
| Yahoo Finance

We issued an updated report on Catalyst Pharmaceuticals Inc. CPRX on May 21. In November 2018, the company’s Firdapse (amifampridine) tablets obtained FDA approval for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults. The drug became the first FDA-approved treatment for LEMS and also the first approved product in Catalyst’s portfolio.