GUARDIAN DRUG HAS FIRST GENERIC VERSION OF MARION's GAVISCON (aluminum hydroxide gel 80 mg and magnesium trisilicate 20 mg) following FDA approval of the generic firm's ANDA on Sept. 4. The Trenton, New Jersey-based generic drug manufacturer said it began filling orders for the OTC antacid product immediately after receiving approval. Guardian is supplying the chewable tablet product, under the tradename Foamcoat Chewable Tablets, to private label and generic drug marketers. The Gaviscon generic is Guardian's first product via the ANDA regulatory route. The privately-held firm markets approximately 15 OTC antacid products that can be sold under the OTC Antacid monograph. Guardian's products, which include generic and private label versions of Norcliff Thayer's Tums, Rorer's Maalox, Warner-Lambert's Rolaids, and Stuart's Mylanta, are sold exclusively to generic and private label firms. The two-and-a-half year old privately-held firm estimates that its 1987 sales will be about $1 mil. According to Marion's 1986 annual report (year ended June 30), sales of the Gaviscon line, which consist of the tablet product, a liquid, and Gaviscon-2 tablets (aluminum hydroxide 160 mg and magnesium trisilicate 40 mg), were roughly $24 mil. Sales of the OTC antacid products have held steady in the $23-$24 mil. range for the last several years. Gaviscon, an NDAed OTC, had a period of market exclusivity under the Waxman/Hatch law that expired Sept. 24, 1986.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
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.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
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.
A new pilot aims to take Brazil closer to ‘digital transformation.’
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
