Oceanside launches generic Librax
ALISO VIEJO, Calif. A division of Valeant Pharmaceuticals has launched an authorized generic of an irritable bowel syndrome treatment.
Oceanside Pharmaceuticals has launched chlordiazepoxide hydrochloride and clidinium bromide, an authorized generic version of Librax. Oceanside has received its first orders and expects to be a significant player in the Librax generic market, the company said.
“Valeant’s Oceanside unit has become an important division of our U.S. business with its successful launch and distribution of 5% fluorouracil, Valeant’s authorized generic of Efudex,” stated J. Michael Pearson, chairman and CEO. “Oceanside currently maintains a 55% market share of its Efudex AG and plans to retain this leadership position in the future. With the industry experience we have had with Efudex AG, we believe that we can successfully grow a strong market position with the launch of Librax AG.”
FDA approves Pharmaforce’s dorzolamide hydrochloride eye drops
ROCKVILLE, Md. The Food and Drug Administration has approved a drug for treating high pressure in the eye, a condition that eventually can lead to blindness.
FDA records show that the agency approved Pharmaforce’s dorzolamide hydrochloride eye drops.
The drug is used to treat high pressure in the eye resulting from open-angle glaucoma and ocular hypertension and is a generic version of Merck & Co.’s Trusopt.
FDA approves Amneal’s GERD generic
ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of a drug for treating gastroesophageal reflux disease in adolescents and adults.
According to FDA records, the agency approved Amneal Pharmaceuticals’ nizatidine oral solution in the 15-mg-per-15-mL strength.
The drug is used to treat symptoms of GERD in patients ages 12 years and older and is a generic version of Axid, made by Braintree Laboratories.