Drugs
FDA has notified Sun Pharma that it will lift the import alert imposed on its Mohali (Punjab) drug manufacturing facility in India, clearing the path for the company to supply approved products from the facility to the U.S. market under standard FDA regulatory requirements. Sun says it inherited the
Drugs
An 8/16-8/19/16 FDA inspection at Badrivishal Chemicals & Pharmaceuticals, Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients, according to a 3/2 Warning Letter. Specific deviations cited in the letter included: * failure to validate and monitor the water
Drugs
A 9/26-9/28/16 FDA inspection at Lumis Global Pharmaceuticals, Wuhan, China, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API), according to a 3/2 Warning Letter. Specific deviations cited in the letter include: * failure to transfer all quality or regulatory information
Drugs
Hogan Lovells attorneys say that 2016 was a year of expansion for the False Claims Act (FCA). The firm’s first annual review of the act and its whistleblower provisions says there were “very significant changes to the way courts apply the FCA.” It references in particular a 6/16/
Drugs
In order to speed drug products through the development process, more resources are needed for FDA to advance activities such as the Critical Path Initiative and the use of new methods for clinical trials (e.g., adaptive trial designs and Bayesian statistical methodologies), according to former FDA commissioner Andrew von
Drugs
FDA has published a guidance on “Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims” that is intended to help applicants in developing labeling for cardiovascular outcome claims for hypertension drugs. “With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood
Drugs
FDA has placed a partial clinical hold on Karyopharm Therapeutics clinical trials for selinexor (KPT-330) due to incomplete information contained in an existing version of the investigator brochure (IB). While the hold remains in effect, patients with stable disease or better may remain on selinexor therapy, the company says,
Drugs
Sunovion Pharmaceuticals has submitted a supplemental NDA to expand the indication for its antiepileptic drug Aptiom (eslicarbazepine acetate) to include use as monotherapy or adjunctive therapy treating partial-onset seizures in children four years of age and older. The drug is currently approved for this indication in adults. Sunovion is
Drugs
Researchers from a number of institutions, led by former FDA principal deputy commissioner Josh Sharfstein, have developed a new “Blueprint for Transparency at FDA.” Sharfstein, now associate dean at Johns Hopkins Bloomberg School of Public Health, led FDA efforts to increase transparency during the early days of the Obama Administration.
Drugs
FDA has approved Novartis’s Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali is a CDK4/6 inhibitor, and it was
Drugs
FDA has granted eFFECTOR Therapeutics an orphan drug designation for lead product candidate eFT508 and its use for treating diffuse large B-cell lymphoma, an aggressive form of non-Hodgkin lymphoma. eFT508 is described by the company as a potent, highly selective inhibitor of MNK1 and MNK2, two enzymes that
Drugs
FDA has denied a Purdue Pharma petition asking it to to ensure that applications for approval of follow-on products citing Purdue’s Butrans (buprenorphine) transdermal system as the reference-listed drug are supported by pharmacokinetic data establishing equivalent buprenorphine exposure over the entire seven-day dosing interval. “Absent such
Drugs
FDA has extended by three months its review of a Radius Health NDA for abaloparatide-SC , indicated for treating postmenopausal women with osteoporosis, to allow additional time to review an agency-requested information request that was recently submitted. The new user fee review target date us 6/30. In its
Drugs
Congresswoman Chellie Pingree (D-ME) has re-introduced the Safe and Affordable Drugs from Canada Act (HR 1480), which would allow Americans to import prescription drugs from Canadian pharmacies. Under the bill, imported prescription drugs would have to be purchased from an approved Canadian pharmacy and dispensed by a licensed
Drugs
Regeneca Worldwide, a division of VivaCeuticals, is recalling its entire line of herbal and dietary supplement products under a consent decree entered by the Central District of California federal court. The recall applies to all products manufactured and sold between 6/2011 and 2/8/2017. Products affected include RegeneSlim,
Drugs
Attorneys Neil O’Flaherty and Jur Strobos (Baker McKenzie) say that FDA has responded to congressional instructions by increasing its inspection focus on foreign drug production sites’ current good manufacturing practices (CGMP) and using its new tool of “refusing inspections” to shut down or impose import alerts on foreign drug
Drugs
Nicox has resubmitted an NDA for AC-170 (cetirizine), an eye drop formulation for treating ocular itching associated with allergic conjunctivitis, after receiving FDA confirmation that GMP concerns surrounding the production site of the active pharmaceutical ingredient have been resolved. In 10/2016, the agency sent a complete response letter
Drugs
Par is asking FDA to modify its denial of a company 8/1/16 petition that asked the agency to take specific steps involving ANDAs for an epinephrine injection 1mg/mL product in a 1 mL vial, ampule, pre-filled syringe, or similar parenteral administration modality. Specifically, the Par petition
Drugs
After meeting 3/9 with Maryland Democrat Elijah Cummings, the White House backed off a commitment Cummings said President Trump made to help Democrats push through legislation to give the federal government power to negotiate drug prices, particularly under Medicare. Cummings had described the president as being very much onboard
Drugs
Epstein Becker Green is asking FDA to establish a reasonable review timeline for assessing appeals of letter of designation decisions from the FDA Office of Combined Products. The firm’s 3/3 petition says that letter of designation decisions may be appealed to the associate commissioner of special medical programs,
Drugs
FDA has granted Boehringer Ingelheim an orphan drug designation for its anti-CD33 monoclonal antibody BI 836858 for treating myelodysplastic syndromes (MDS). “Preclinical studies with our anti-CD33 monoclonal antibody have shown promising therapeutic potential in myelodysplastic syndromes, a rare group of bone marrow disorders,” the company says. A Phase
Drugs
The Dr. Reddy’s oncology drug formulation manufacturing facility at Duvvada, Visakhapatnam, India, that was one of the facilities named in a 2015 Warning Letter, has been issued an FDA-483 containing 13 inspection observations, according to a company statement to India financial regulators and the New York Stock Exchange.