Please login to the form below

Not currently logged in
Email:
Password:

Sun gets FDA marketing nod for Protonix

Sun Pharmaceutical wins FDA approval for its ANDA to market a generic version of Wyeth's Protonix tablets

India-headquartered generic manufacturer Sun Pharmaceutical has won FDA approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Wyeth's Protonix tablets (pantoprazole).

Pantoprazole is indicated for the short-term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis and for the treatment of hypersecretory diseases.

Sun's generic pantoprazole tablets are copies of Wyeth's Protonix Delayed Release Tablets and include 20 mg and 40 mg doses, both of which post annual US sales of around USD 2.3bn.

Sun, which was the first-to-file its generic Protonix ANDA with a Paragraph IV certification, also gains a 180-day marketing exclusivity.

Sun stated that it was now mulling its launch options.

30th September 2008

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
StratX

StratX creates experiential learning programs instilled with emotion and competitive spirit, leading to lasting on-the-job change. Our memorable approach develops...

Latest intelligence

How can pharma engage with key stakeholders on NHS service transformation?
Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare consulting team, explain how pharma should make its case for change...
michael elliot
The race for an HIV ‘cure’
Supercharging therapies as pharma and patients work together...
Medopad: the up and coming unicorn transforming remote patient monitoring
Blue Latitude Health speaks to Medopad’s Martha Carruthers to learn how the start-up’s modular apps are helping patients with complex diseases....

Infographics