Generic Line

Most who are following the user fee bills pending in Congress expect lawmakers to combine the Generic Drug User Fee Act (GDUFA) with legislation to address the escalating problem of drug shortages.

The FDA has issued three long-awaited biosimilars guidance documents, recommending a stepwise approach to showing biosimilarity that could allow eased trial requirements if a sponsor can demonstrate biosimilarity in earlier steps.

Congress is starting to ask FDA officials questions about generic-drug makers’ ability to conduct bioequivalence (BE) studies on brand drugs in short supply, and the issue may be addressed in upcoming Generic Drug User Fee Act (GDUFA) authorization.

Delayed progress on the Medical Device User Fee Act (MDUFA) and the threat of a bevy of amendments could hinder quick passage of the Generic Drug User Fee Act (GDUFA) and Biosimilars User Fee Act (BSUFA).

Ben Venue subsidiary Bedford Laboratories is voluntarily recalling one lot of its overdose drug acetylcysteine solution USP after finding a single glass particle in a 30 mL vial, the FDA says.

A federal judge has sided with the FDA, ruling it was correct in approving Sandoz’s generic version of Sanofi’s blockbuster blood-thinner Lovenox.

Like many drugmakers, Dr. Reddy’s Laboratories is looking to more complex products — particularly biosimilars — to drive future growth.

AstraZeneca may have lost two years of patent coverage on its blockbuster statin Crestor after an appeals court ruled several generic-drug makers weren’t infringing on two of the drug’s patents.

Analysts are questioning the approvability of Watson Pharmaceuticals’ ANDA for pain patch Lidoderm as documents show the FDA rejected certain bioequivalence studies from the generic-drug maker.

Marketing applications for drugs in short supply could see expedited review under the Drug Shortage Prevention Act introduced in the House Jan. 31.

Biosimilars makers are intimately familiar with certain hurdles for success in the marketplace; untested regulatory pathways, patent challenges and manufacturing issues.

The floodgates of generic versions of Lipitor are starting to bulge as the FDA tentatively approved Mylan’s ANDA for the drug.

Drugmakers must include authorized generics in the calculation of average manufacturer price (AMP) when an NDA holder sells its product directly to a wholesaler, under a proposed rule.