Posts tagged 505(b)(2)
Tetra Bio-Pharma updates Dronabinol XL AdVersa development plans

Tetra Bio-Pharma (TSXV:TBP; OTCQB:TBPMF) is partnering with a major manufacturer of controlled active pharmaceutical ingredients in the U.S. to  manufacture Dronabinol XL AdVersa as part of the company’s plans to submit a 505(b)(2) NDA for the treatment of chemotherapy-induced nausea and vomiting and anorexia associated with weight loss in patients with AIDS.

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IntelGenx, RedHill Biopharma resubmit RIZAPORT NDA to FDA

IntelGenx (OTCQX:IGXT; TSXV:IGX) and RedHill Biopharma (NASDAQ, TASE:RDHL) resubmitted the 505(b)(2) NDA to the FDA for RIZAPORT 10 mg, an oral thin-film formulation of rizatriptan for the treatment of acute migraines.

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IntelGenx, RedHill RIZAPORT cleared in Luxembourg

IntelGenx (OTCQX:IGXT; TSX-V:IGX) and RedHill Biopharma (NASDAQ, TASE:RDHL) announced that the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT (5 mg and 10 mg), an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.

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IntelGenx to license tadalafil patent from Lilly

IntelGenx (OTCQX:IGXT; TSX-V:IGX) has signed a binding term sheet to license Eli Lilly's tadalafil dosing patent. Any exclusivity associated with the tadalafil compound patent is not affected by the agreement.

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Titan Pharma receives FDA feedback on Parkinson’s implant

The FDA has provided written feedback to Titan Pharmaceuticals (NASDAQ:TTNP) on the initial development plan for its proprietary ropinirole hydrochloride implant for Parkinson’s disease.

Based on the FDA’s feedback on the development plan submitted in December 2015, Titan is proceeding with the required non-clinical studies to support a potential IND submission in the fourth quarter of 2016, followed by an initial pharmacokinetic and proof-of-concept clinical study. Titan is pursuing a 505(b)(2) registration pathway for the implant.

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