The Company's poster titled, 'Steady-State Pharmacokinetic Properties of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL): Comparison to Simulations of Oral Immediate Release CBP' reports PK results of TNX-102 SL, a sublingual form of cyclobenzaprine studied in a comparative PK, open-label, randomized, parallel, two-arm, multiple-dose pivotal bridging study, with the reference listed drug AMRIX
(cyclobenzaprine HCI extended release capsules).
Adare has developed and manufactured more than 40 products sold by partners in more than 100 countries globally including Lacteol, Zoolac, Viactiv, Amrix
and a number of branded and complex generic products.
Drug Brand Names Amitriptyline * Elavil, Endep Methadone * Dolophine, Bupropion * Wellbutrin, Methadose Zyban Milnacipran * Savella Carisoprodol * Rela, Soma Mirtazapine * Remeron Cydobenzaprine * Amrix
, Nortriptyline * Pamelor Flexeril Paroxetine * Paxil Desipramine * Norpramin Pregabalin * Lyrica, Lyrica CR Desvenlafaxine * Pristiq Tapentadol * Nucynta Duloxetine * Cymbalta Tramadol * Ultram Fluoxetine * Prozac Trazodone * Desyrel, Oleptro Gabapentin * Horizant, Venlafaxine * Effexor Neurontin Warfarin * Coumadin, Imipramine-Tofranil Jantoven Levomilnacipran * Fetzima Bottom Line
CR (Canada) (Canada) Cyclobenzaprine Amrix
The agreement grants Par the ANDAs of fentanyl citrate lozenges, a generic version of Actiq; cyclobenzaprine ER capsules, the generic version of Amrix
; and the US rights to market modafinil tablets, the generic version of Provigil.
The US trade regulator, the Federal Trade Commission, made the merger conditional on Teva's divestment of its Provigil generic, its Actiq generic used to treat cancer and Amrix
, a muscle relaxant.
The transaction has been approved by the US Federal Trade Commission (FTC) last week, after Teva agreed to give marketing rights to its Provigil drug to sector firm Par Pharmaceuticals (NYSE:PRX) for one year, and to sell Par the rights and assets of the generic versions of the Actiq and Amrix
Sales of muscle relaxant Amrix
fell 4% to $25.1 million, while overall pain treatment sales fell 7% to $113.6 million.
The company's proprietary products in the United States include: AMRIX
(cyclobenzaprine hydrochloride extended-release capsules), TREANDA (bendamustine hydrochloride) for Injection, FENTORA (fentanyl buccal tablet) (C-II), PROVIGIL (modafinil) Tablets (C-IV), TRISENOX (arsenic trioxide) injection, GABITRIL (tiagabine hydrochloride), NUVIGIL (armodafinil) Tablets (C-IV) and ACTIQ (oral transmucosal fentanyl citrate) (C-II).
The transaction secured US Federal Trade Commission's (FTC) approval last week, after Teva agreed to sell two abbreviated new drug applications (ANDAs) for its fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix
, to sector firm Par Pharmaceuticals (NYSE:PRX).
Under the FTC's consent order, Teva is required to divest two Abbreviated New Drug Applications (ANDAs) for fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix