Generic Line

The FDA hopes to take harsh measures to deal with its ANDA backlog, saying it would refuse to receive any new ANDAs or supplements from generic-drug makers that do not pay a one-time ‘backlog’ fee under the pending Generic Drug User Fee Act (GDUFA) agreement.

All eyes of the generic-drug industry will be focused on Capitol Hill this year as Congress readies to take action on the proposed Generic Drug User Fee Act (GDUFA) after years of FDA and industry efforts on the agreement.

The FDA plans to issue draft guidance by mid-2014 on the various product development meetings included in its proposed biosimilars user fee program the agency unveiled last month.

Indian generic-drug giant Ranbaxy Laboratories entered into a consent decree with the FDA to resolve lingering manufacturing problems at two plants.

FDA decisions on ANDAs or 505(b)(2) applications would not be delayed by pending citizen petitions, or petitions for stay of action, unless a delay is necessary to protect public health, under a new proposed rule.

Generic versions of blockbuster cholesterol drug Lipitor raked in roughly 60 percent of sales during their first two weeks on the market, with Watson’s authorized generic beating Ranbaxy’s competitor.

The FDA has issued an interim final rule requiring drugmakers to report interruptions in the production of critical drugs.

If Congress mandates early alerts about drug shortages, implementation should get close monitoring and there should be audits of the FDA process for collecting data from drugmakers, an expert tells senators.

Concerned about the upward trend in supplier quality issues, the FDA is considering agency-wide guidance to clarify manufacturers’ responsibilities for outsourcing, an agency official says.

Patent use code descriptions for drugs listed in the FDA’s Orange Book should be identical to language in the method-of-use patent to prevent NDA holders from arbitrarily changing the codes to prevent generic competition, a pair of industry attorneys assert.

Even though the FDA hasn’t released details on how its abbreviated approval pathway for biosimilars will work, the agency has already held 21 pre-IND meetings on 11 reference biologics and received seven INDs, said Leah Christl, CDER’s associate director for biosimilars.

The FDA is asking Novartis for a comprehensive, global manufacturing assessment after it sharply scored the company for multiple repeated quality failures at plants operated by its Sandoz subsidiary.

A proposed Medicare Payment Advisory Commission (MedPAC) recommendation for wider copays between brand and generic drugs may lead to greater use of the cheaper medicines under Medicare Part D.

Brand- and generic-drug makers continue to buddy up on biosimilars development with Baxter and Momenta Pharmaceuticals and Watson Pharmaceuticals and Amgen inking collaboration agreements.