Content about New Drug Application

ALLEGAN, Mich. — Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

Zantac 150 has annual sales of approximately $110 million, as measured by SymphonyIRI Group, Perrigo reported.

LONDON — GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.

The drug maker said its abbreviated new drug application for ranitidine syrup in the 15-mg/mL strength was approved. Ranitidine syrup is a generic version of GlaxoSmithKline’s Zantac syrup, which garnered sales of $21 million for 12 months ended in December 2010, according to IMS sales data.

Hi-Tech currently has 13 products awaiting approval at the FDA, the company said.

POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.

LONDON — A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

The drug maker recently announced that the Food and Drug Administration asked AstraZeneca to submit a Risk Evaluation and Mitigation Strategy, which accordingly extended the Prescription Drug User Fee Act from Jan. 7 to April 7.

AstraZeneca will continue to work closely with the FDA to support the review of vandetanib, a drug for treating patients with advanced medullary thyroid cancer.

HAYWARD, Calif. — A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

SILVER SPRING, Md. The Food and Drug Administration on Tuesday issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. According to the FDA, these claims suggested the products are effective in preventing gum disease when no such benefit has been demonstrated.

Warning letters were sent to: Johnson & Johnson (Listerine total care anti-cavity mouthwash), CVS (CVS complete care anti-cavity mouthwash), and Walgreens (Walgreen mouth rinse full action).

LONDON The Food and Drug Administration has pushed back its review date for a drug made by GlaxoSmithKline and Valeant Pharmaceuticals.

The FDA has not yet completed the review of the new drug application for ezogabine, a drug designed to treat epileptic adults with partial onset seizures, after a formal risk evaluation and mitigation strategy was submitted to the agency from GSK and Valeant, per its request.

The FDA is expected to review the application by Nov. 30.

WASHINGTON While there is a need to modernize the regulatory structure of the cosmetics industry, the newly proposed Safe Cosmetics Act of 2010 as written "is not based on credible and established scientific principles" and would place an "enormous, if not impossible, burden on the Food and Drug Administration," the Personal Care Products Council stated in response to the legislation introduced on Wednesday.