Drugs
FDA has approved an Ortho Dermatologics NDA for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients nine years of age and older. Altreno is the first formulation of tretinoin in a lotion, according to the company. In clinical trials, the lotion demonstrated proven
Drugs
The Senate 8/23 passed a bipartisan amendment introduced by Sens. Chuck Grassley (R-IA) and Dick Durbin (D-IL) that provides Health and Human Services with $1 million to implement rules requiring pharmaceutical companies to list prices of their prescription drugs in direct-to-consumer advertisements. “The amendment helps
Drugs
An FDA 4/16 public workshop on Evaluating Inclusion and Exclusion Criteria in Clinical Trials addressed the underrepresentation of various populations in clinical trials, how eligibility criteria affect patient access to investigational drugs and enrollment in clinical trials, alternative clinical trial designs that may increase the enrollment of diverse populations,
Drugs
FDA has approved a Biocodex SAS NDA for Diacomit (stiripentol) for treating seizures associated with Dravet syndrome in patients two years of age and older taking clobazam. Approval was based on data from two multicenter placebo-controlled trials, STICLO France and STICLO Italy. The primary efficacy endpoint in both trials
Drugs
FDA has approved a Kala Pharmaceuticals NDA for Inveltys (loteprednol etabonate ophthalmic suspension) 1% for treating post-operative inflammation and pain following ocular surgery. The drug is the first twice-daily ocular corticosteroid approved for this indication, according to the company. All other ocular steroids are only approved for four-
Biologics
FDA has published a draft guidance, Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment, to assist sponsors who are developing medical products to treat the underlying pathophysiology and structural progression of osteoarthritis. The document says that approvals for osteoarthritis to date have been based
Drugs
FDA commissioner Scott Gottlieb says the agency has contracted with the National Academies of Sciences, Engineering, and Medicine to help advance development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. “The primary scope of this work is to understand what
Drugs
The 3rd Circuit Court of Appeals upheld a Pennsylvania federal court ruling dismissing a whistleblower suit brought by several states against nine drug companies alleging that they underpaid rebates to the states under the Medicaid Drug Rebate Program. The appeals court decision says the central issue was whether the companies
Drugs
FDA has issued Allergan a complete response letter on its NDA for ulipristal acetate, indicated for treating abnormal uterine bleeding in women with uterine fibroids. The letter requests additional information and cites safety concerns regarding post-marketing reports outside the U.S., according to the company. Allergan plans to meet
Drugs
FDA has approved Dompe Farmaceutici’s Oxervate (cenegermin), the first drug approved for treating neurotrophic keratitis, a rare corneal disease. An agency statement says the drug’s safety was studied in 151 patients in two eight-week studies. Across both studies, the agency says, complete corneal healing in eight weeks
Drugs
FDA has issued a complete response letter (CRL) for Mallinckrodt’s stannsoporfin, a heme oxygenase inhibitor under investigation for treating newborns with indicators of hemolysis who are at risk of developing severe jaundice. The company says the agency provided guidance about areas of further evaluation for resubmitting the stannsoporfin NDA.
Drugs
A 3/26-3/29 FDA inspection at Hangzhou Karic Commodities Co., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/31 Warning Letter identified specific violations as: * failing to have, for each batch of drug product, appropriate laboratory determination of
Drugs
The National Alliance on Mental Illness (NAMI) says an FDA draft guidance on developing drugs to treat major depressive disorder “is long overdue. It is important for the agency to take steps to improve the drug review process and ensure greater transparency and improvement about the review process…. This guidance
Drugs
Sen. Edward Markey (D-MA) says it’s possible that FDA ignored red flags that may have resulted in inappropriate prescribing of a certain class of immediate release fentanyl products. In a statement, he referenced an analysis of the FDA REMS (Risk Evaluation and Mitigation Strategies) for the class of
Drugs
A 9/4-9/8/17 FDA inspection at Kyowa Hakko Bio Co., Yamaguchi, Japan, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to an 8/10 Warning Letter. Specific deviations cited in the letter were: * failure of the quality unit to exercise
Drugs
To help mitigate an EpiPen shortage, FDA says it is extending by four months the expiration date for specific lots of EpiPen that are expired or close to expiring. An agency notice cites information from Mylan showing the specific lots involved with the original and new expiration dates. “While product
Drugs
JAMA deputy editor Gregory Curfman says it is “troublesome” that in most jurisdictions, both generic and innovator drug companies are protected from legal liability stemming from failure-to-warn claims. “Congress should fully consider this issue and fill the gap in the current legal framework through legislation,” he writes in
Drugs
FDA has granted Audentes Therapeutics a regenerative medicine advanced therapy (RMAT) designation for AT132 and its use in treating X-linked myotubular myopathy. The RMAT designation was granted based on positive interim clinical data from ASPIRO, an ongoing Phase 1/2 clinical study. The data, according to the company, showed
Drugs
FDA has approved a Merck expanded label for Keytruda in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. The approval was based on results of the KEYNOTE-189
Drugs
FDA has posted a guidance on “Quality Attribute Considerations for Chewable Tablets” that provides the agency’s current thinking on the critical quality attributes that should be assessed during the development of such products. It also provides recommendations for sponsors/applicants regarding the submission of developmental, manufacturing, and labeling information
Drugs
FDA has posted a guidance on “Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.” The document is intended to assist sponsors regarding nonclinical studies recommended to support human clinical trials and marketing applications. It discusses how to refine nonclinical study recommendations for this class of drug given its unique characteristics ( e.
Drugs
FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, and finished drug manufacturers that Sichuan Friendly Pharmaceutical Co. Limited (China) has recalled certain lots of porcine thyroid API due to inconsistent quality of the API. FDA recommends that manufacturers and compounders not use this API received since 8/2015.