Quinidine sustained release
Executive Summary
Robins submits ANDA suitability petition for 200 mg and 400 mg sustained-release tabs. Firm currently markets a 300 mg product, Quinidex Extentabs Tablets, which were declared safe and effective following a 1972 DESI review.
You may also be interested in...
Amneal Eyes Avastin And Praises $120m Biosimilar Development Savings
Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.
Zydus Cadila Testing Three-Dose COVID-19 Vaccine
Zydus Cadila is to begin testing a three-dose recombinant DNA vaccine candidate in Phase III Indian trials, which might enter late-stage development ahead of Inovio and AnGes. The company promised to provide 100-150 million doses by end of 2021 at the J.P. Morgan Conference, though adherence could be a roadblock.
Six Questions For Sun Pharma MD Shanghvi
Sun Pharma’s founder and MD shares with Scrip his views on some key big picture issues, including leveraging pandemic-related regulatory experience for urgently needed products, expectations in the US market, the outlook for M&A, and the potential of e-pharmacies in India.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: