Generic Line

The Medicare payment for the colon cancer drug irinotecan was more than double the calculated average manufacturer sales price in March, despite the availability of generic alternatives, a report by HHS’ Office of Inspector General (OIG) said.

The FDA is questioning a decision by Novartis subsidiary Sandoz to continue distributing generic versions of Toprol XL when the company did not adequately validate its production process.

Barr Pharmaceuticals’ subsidiary Pliva-Lachema has received final approval from the FDA to market its generic version of Pfizer’s myeloma drug Aredia.

The FDA has informed companies holding applications for midodrine HCl that they must obtain approval of postmarketing studies verifying the clinical benefit of their product or the agency will initiate proceedings to withdraw approval of the applications.

The Office of Generic Drugs (OGD) has issued a clarification identifying the information that will be considered acceptable for demonstrating compliance with a U.S. Pharmacopeia (USP) standard for controlling residual solvents that took effect July 1.

A federal district court judge has ruled that three antitrust cases against Barr Pharmaceuticals filed by direct purchasers cannot be decided on summary judgment.

Hi-Tech Pharmacal has filed a complaint against the FDA requesting a declaratory judgment related to the company’s ANDA for a generic version of Merck’s Cosopt, a glaucoma treatment.

The Swedish drug company Meda Pharmaceuticals has settled its U.S. patent infringement lawsuit against the Canadian drug company Cobalt Pharmaceuticals.

A federal appeals court has affirmed a district court’s decision that Apotex and Impax infringed on patents covering AstraZeneca’s heartburn drug Prilosec.

Barr Laboratories is facing a lawsuit for challenging patents covering the antipsychotic FazaClo 25- and 100-mg tablets.

Denmark’s Eastern High Court has ruled in Pfizer’s favor against generics company Ranbaxy in challenges to two of its patents on atorvastatin, Lipitor’s active ingredient.