Drugs
FDA says Hospira is recalling three lots of labetalol hydrochloride injection 100 mg/20 mL vial and one lot of labetalol hydrochloride injection to the hospital/institution level due to discovery of cracks on the rim surface of vials for the lots, which is covered by the stopper and crimp
Drugs
FDA is expected to release soon two new draft guidances intended to advance medication-assisted treatment (MAT) for opioid addiction. Speaking at the 2/24 National Governors Association annual meeting in Washington, DC, HHS secretary Alex Azar said one guidance will encourage more flexible and creative MAT study designs. “As
Drugs
FDA has released the FDA-483 issued following a 10/16-10/27/17 inspection at a Hospira sterile drug manufacturing facility in McPherson, KS. The 10 inspection observations were: * failing to thoroughly review any unexplained discrepancy whether the batch has been already distributed; * employees engaged in the manufacture and
Drugs
Avalere Health says the FDA 1/2017 draft guidance on interchangeability for biologics is “cautious and demanding,” and meeting it would be so costly that it would be difficult for biosimilar manufacturers to achieve a return on their investment. It says the White House Council of Economic Advisors in a
Drugs
The just-released FDA-483 issued following a 1/13-1/20/17 inspection at the Bayer Pharma facility in Leverkusen, Germany, that produces parenteral, solid oral dosage, and active pharmaceutical ingredient drugs contains 11 inspection observations. Specific violations were: * failing to ensure appropriate environmental conditions for filling parenteral products;
Drugs
The FDA-483 issued following a 1/15-1/19 FDA inspection at Indoco Remedies, Goa, India, lists eight inspection observations: * laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards and electronic records do not meet
Drugs
FDA has published a guidance, Q11 Development and Manufacture of Drub Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers, to give additional clarification and to promote convergence and improve harmonization of the consideration for the selection and justification of starting materials and of the information that should be
Drugs
FDA has approved a KemPharm NDA for Apadaz (benzhydrocodone, and acetaminophen) for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The U.S. Drug Enforcement Administration has indicated that it will schedule
Drugs
FDA has accepted for review a Mallinckrodt NDA for stannsoporfin, indicated for treating neonates at risk for developing severe hyperbilirubinemia, or severe jaundice. Stannsoporfin is a heme oxygenase inhibitor under investigation for its potential to reduce the production of bilirubin in at-risk infants. FDA has set a user fee
Drugs
FDA has accepted Shire’s BLA for lanadelumab and will give it a priority review for preventing angioedema attacks in patients age 12 and older with hereditary angioedema (HAE), a rare genetic disorder. The company says that if it is approved, lanadelumab will be the first monoclonal antibody for HAE,
Drugs
FDA says its review of the results of a 10-year follow-up study of patients with coronary heart disease further supports the risk of prescribing AbbVie’s antibiotic Biaxin (clarithromycin) and generics because of a potential increased risk of heart problems or death that can occur years later. An
Drugs
CNBC reports that despite pressure from President Donald Trump for Congress to pass “right-to-try” legislation giving terminally ill patients access to experimental drugs, FDA commissioner Scott Gottlieb is seeking changes in the legislation. In 8/2017, CNBC reports, the Senate passed on a unanimous vote a bill allowing
Drugs
A PricewaterhouseCoopers Health Research Institute report says FDA approved 763 generic drugs in 2017, up 14% from the 651 approved the previous year. The Washington Examiner reports that a major reason for the increased number of generic drug approvals was the agency’s year-long effort to speed the generic
Drugs
The Federal Trade Commission (FTC) says Telomerase Activation Sciences and its CEO have agreed to stop making false and unsupported claims about its two anti-aging products. FTC said the company lacked the scientific evidence to support claims that its capsules, powders, and creams could provide a broad range of
Drugs
FDA has accepted for review a Medicines360 supplemental NDA that seeks to extend the duration of use for preventing pregnancy from up to four years to up to five years for Liletta (levonorgestrel-releasing intrauterine system) 52 mg. The submission is based on additional efficacy and safety data from a
Drugs
FDA has accepted for filing a Medicines360 sNDA to extend the duration of use of its Liletta (levonogestrel-releasing intrauterine system) 52 mg from up to four years to up to five years. The company says the sNDA is currently being reviewed by the agency based on additional efficacy and
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should abandon its efforts to develop a devices referencing drugs (DRD) pathway, while the Advanced Medical Technology Association (AdvaMed) strongly endorses the proposal. In its comment letter. PhRMA says DRDs “pose numerous significant public health, safety, scientific, regulatory, and legal issues
Drugs
FDA has posted a Web page with links to documents relating to the long-term goal of improving the predictability and consistency of the electronic submission process and enhancing transparency and accountability of FDA information technology related activities. Under the heading of improving the predictability and consistency of PDUFA electronic
Drugs
FDA says Divinity Products Distribution, Grain Valley, MS, has destroyed and recalled a large volume of kratom-containing dietary supplements it manufactured and distributed nationwide under three brand names. An agency news release says the company also agreed to stop selling all products containing kratom. “Based on the scientific evidence
Drugs
BIO says FDA should expand a draft guidance on developing targeted therapies in low-frequency molecular subsets of a disease to provide further thinking on the agency’s receptivity to innovative approaches for developing targeted therapies. In its comment, BIO also recommends the draft guidance reflect a scenario in which
Drugs
FDA has sent a second complete response letter to Apricus Biosciences on its NDA for Vitaros (alprostadil topical cream) for treating erectile dysfunction. The company says the letter indicates that the agency cannot approve the submission in its present form, identifying deficiencies related to chemistry, manufacturing and controls and certain
Drugs
FDA has accepted for review an Acorda Therapeutics NDA for Inbrija (inhaled levodopa) for treating symptoms of Off periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The agency has set a user fee review action target date of 10/5. The submission includes data from a