Actavis on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for a generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride extended-release tablets 8 mg, 12 mg and 16 mg).
Actavis on Monday announced that it has entered into an agreement with Valeant Pharmaceuticals International to settle all outstanding patent litigation related to Actavis' generic version of Acanya (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%.
Mylan last week announced that it filed suit against the Food and Drug Administration, challenging the agency's decision regarding generic drug marketing exclusivity on celecoxib capsules, the generic equivalent of Pfizer's Celebrex.
Actavis on Tuesday announced that it has entered into an agreement with Mylan and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).
The National Association of Boards of Pharmacy recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.
Actavis earlier this week announced that it has entered into an agreement with Noven Pharmaceuticals to settle all outstanding patent litigation related to Actavis' generic version of Daytrana (methylphenidate transdermal system).
The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties.
Following the announcement that Rep. Henry Waxman, D-Calif., intended to retire, the Generic Pharmaceutical Association bid adieu to a legislator who had a tremendous positive impact on the generic industry.
For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.
Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.
The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.
Anda VP purchasing Marc Falkin wrote in an email to coworkers and friends that he would begin working for Actavis as VP marketing, pricing and contract operations for the Parsippany, N.J.-based drug maker's generics business.
The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said.