Generic Line

Due to summer holidays, Generic Line will not be published July 4. The next issue will be published July 18.

Generic-drug makers are raising concerns with their access to House user fee bill discussions because unlike the Senate, House lawmakers didn’t hold a joint meeting with the FDA, PhRMA and GPhA on certain cost-saving provisions of its FDA user fee bill.

The FDA’s Office of Generic Drugs (OGD) appears to be taking the first steps to whittling down its almost 3,000-long ANDA backlog, telling drugmakers it will discard 364 pending generic-drug applications unless told otherwise.

Congress is pointing a finger at the FDA for spurring the increase in drug shortages through stepped up enforcement actions, despite the agency’s efforts to mitigate the trend.

Biologics, like small-molecule drugs, may get a break on early shortage notification requirements as the reconciled FDA user fee bill gives the agency enforcement discretion for these products. 

Some Democratic lawmakers are pushing for a drug pedigree system to combat potential “gray marketing” of shortage drugs, arguing that a national track-and-trace system would not be enough to secure the supply chain.

A packaging error is causing Sandoz to recall 10 lots of a generic oral contraceptive Introvale.

BALTIMORE — Drug shortages, poor product quality, poor corrective actions and other “manufacturing breakdowns” have conspired to create a crisis state that demands not only strong regulatory enforcement, but also active collaboration among drugmakers to address the issue, FDA officials say.

Proponents of biosimilars carrying the same name as their reference biologic got a boost from a coalition of consumer advocates who penned a letter to FDA Commissioner Margaret Hamburg urging same-name use.

BALTIMORE — Proposed language redefining current good manufacturing practices (cGMP) included in omnibus FDA user fee legislation appears to give the agency new authority to require drugmakers to make supplier quality agreements, a compliance expert says.

The biosimilars development arena gained another brand-generic drugmaker partnership as Dr. Reddy’s and the German Merck KGaA plan to collaborate on the treatments.

Mylan can commence U.S. generic sales of the sleep disorder drug Provigil on Aug. 10, before the end of Teva’s 180-day marketing exclusivity period, under a settlement reached by the two companies.

Pfizer is again facing antitrust lawsuits from pharmacies claiming it used fraudulent tactics to block and delay generic forms of its blockbuster antidepressant Effexor XR.

Citing particulate and specification concerns, Teva is voluntarily recalling tens of thousands of bottles of generic hypertension drugs and five lots of generic oral contraceptives, the FDA says.

The House version of the FDA’s fiscal 2013 spending bill mandates the agency provide the Office of Generic Drugs $52.5 million next year.