Leiner

Private labeler to begin shipping generic famotidine 10 mg, marketed under ANDA approval granted to Dr. Reddy's Labs, by Oct. 1. Dr. Reddy's ANDA 75-758 for J&J/Merck Pepcid AC equivalent received FDA clearance Aug. 17; Leiner currently markets generic ranitidine 75 mg (Pfizer/Warner-Lambert's Zantac 75) for Dr. Reddy's. Leiner joins Perrigo (marketing under a license from Teva) and Ivax in OTC generic famotidine market (1"The Tan Sheet" Aug. 6, In Brief)

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By 

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Test H1 Heading

Test H1 Story

Shape Our Content: Take The Reader Survey

 
• By 

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

More from Pink Sheet

COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
• By 

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

Nancy Tests New Podcast Template

 

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

PinkSheet-R&D-Free: ‘Ranking’ article that includes different Composer content

 
• By 

To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.