Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Generic Pravachol approval

This article was originally published in The Tan Sheet

Executive Summary

FDA approves Barr Pharmaceuticals and subsidiary Pliva's generic version of Bristol-Meyers Squibb's cholesterol drug Pravachol Nov. 28. The Woodcliff Lake, N.J.-based company says it plans to launch 10 mg, 20 mg and 40 mg of the pravastatin product immediately. Barr also says Pliva received tentative approval for its pravastatin 80 mg and plans to launch it following the expiration of a competitor's 180-day generic drug exclusivity period. Watson announced in May its launch of a generic Pravachol following FDA approval of Teva's ANDA (1"The Tan Sheet" May 1, 2006, p. 12)...

You may also be interested in...

Generic Pravastatin Reaches Market With Teva ANDA Approval

Watson is launching its authorized generic version of Bristol-Myers Squibb's Pravachol (pravastatin) following FDA approval April 24 of Teva's ANDA to market the 10 mg, 20 mg and 40 mg doses of the drug

Ready, Set, Guidance: FDA Releases Final Details Ahead Of ASCA Pilot Launch

A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.

With Preservative-Free Alaway Eye Drops, Bausch Expands OTC Portfolio Of Planned Spin-Off

Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals. 





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts