Private label manufacturer preparing to launch extended-release acetaminophen in anticipation FDA will approve its ANDA by year end. Promotional material at the PLMA annual trade show in Chicago compares the 650 mg pain reliever/fever reducer "to the active ingredient in Tylenol Arthritis." In July 1998, McNeil relaunched Tylenol Extended Relief under the name Tylenol Arthritis Extended Relief Caplets (1"The Tan Sheet" July 6, 1998, p. 18). Allegan, Mich.-based Perrigo also expects agency approval of its ANDA for 5% minoxidil topical solution "well before" Pharmacia & Upjohn's three-year marketing exclusivity expires Nov. 14, 2000. Alpharma's ANDA for private label Rogaine Extra Strength for Men was tentatively approved July 22 (2"The Tan Sheet" Aug. 2, In Brief)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
