FDAnews Drug Daily Bulletin

The FDA has sent Navidea a complete response letter (CRL) on its Lymphoseek injection, citing concerns over quality control at third-party contract manufacturing facilities.

Environmental monitoring programs, increasingly under scrutiny by FDA investigators, require continuous, top-level oversight and procedural accuracy to be effective, compliance experts say.

The FDA has approved Novartis’ Afinitor to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA) in children, expanding its indication for the condition.

Weekly prescriptions for Merck’s asthma and allergy treatment Singulair (montelukast) plunged nearly 90 percent within four weeks of the August introduction of competing generic copies.

India’s Supreme Court has given the government two weeks time to finalise its long-pending drug pricing policy, failing which it will pass an interim order, according to a lawyer representing the health group that is pushing for cheaper essential drugs.

Jazz Pharmaceuticals announced a new patent related to Xyrem (sodium oxybate) oral solution titled “Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy” was issued.

Pfizer announced that the World Health Organization has granted an expansion to the prequalification of Pfizer’s pneumococcal conjugate vaccine, Prevenar 13, to include adults 50 years of age and older against pneumonia and invasive disease caused by the 13 pneumococcal serotypes contained in the vaccine.

Pfizer announced that the World Health Organization has granted an expansion to the prequalification of Pfizer’s pneumococcal conjugate vaccine, Prevenar 13, to include adults 50 years of age and older against pneumonia and invasive disease caused by the 13 pneumococcal serotypes contained in the vaccine.

Dr. Reddy’s Laboratories has introduced Metoprolol Succinate extended-release tablets of 25-mg, 50-mg, 100mg and 200-mg strengths in the U.S.