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Pfizer and its generic injectables arm, Hospira, received a complete response letter for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited in a February FDA warning. Read More
The owner and compliance director of Pharmakon Pharmaceuticals routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results showed the strength was often nearly double what it should have been, covered up the error and lied to FDA investigators rather than notifying the FDA or customers, according to a 10-count federal indictment. Read More
A federal district judge shut down drugmaker Stratus Pharmaceuticals in Florida and distributor Sonar Products of New Jersey with a permanent injunction Thursday. Read More
Phillips Co. is voluntarily recalling all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed after an FDA inspection found significant manufacturing practices that call into question “the safety, identity, strength, quality and purity” of unexpired drug products made at the firm in the past three years. Read More
The FDA plans to use its emerging technology program to help address key pharmaceutical quality and manufacturing challenges — and also train agency reviewers on the latest processes to keep pace with industry innovation. Read More
Quality issues and violations of FDA current good manufacturing practices are plaguing Hospira, triggering a series of recalls, contributing to a drug shortage and costing the drugmaker’s parent company a biosimilar license for a second time. Read More
The FDA cited a Plattsburgh, N.Y., outsourcing facility after an inspection in February and March found serious deficiencies in the company’s cleanliness and sterility practices. Read More
The FDA warned Raritan Pharmaceuticals for violating GMP standards, noting the firm failed to properly test its products, which are meant for vulnerable populations, or to maintain good quality control practices. Read More