Drugs
Federal Register notice: FDA has withdrawn the approval of an Upsher-Smith Laboratories ANDA for zaleplon (reference product: Sonata) capsules, 5 mg and 10 mg. The company requested the withdrawal after being contacted by FDA about concerns with the validity of bioequivalence data from studies conducted by an unnamed contract
Drugs
Former FDA commissioner Robert Califf says a sweeping overhaul of the current clinical trial system is needed and underway. Writing in the Journal of the American Medical Association, Califf acknowledges complaints that the current system moves too slowly to approve new drugs or rushes new drugs to market without adequate
Drugs
FDA has posted a transcript of a 7/19 public meeting on Hatch-Waxman Amendments and its discussion on whether an appropriate balance is still maintained between brand and generic companies since the law was enacted in 1984. At the meeting, FDA commissioner Scott Gottlieb outlined new approaches the agency
Drugs
FDA has accepted for review a Portola Pharmaceuticals BLA resubmission for AndexXa (andexanet alfa) and its use as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled or life-threatening bleeding event or who require urgent or emergency surgery.
Drugs
A 2/20-23/17 FDA inspection at Foshan Flying Medical Products, Foshan City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 8/1 Warning Letter. Specific violations cited were: * failing to establish an adequate quality control unit and procedures applicable
Drugs
A 1/9-1/13 FDA inspection at Homeolab USA, Montreal, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 8/2 Warning Letter. Specific violations cited in the letter were: * failing to establish and follow adequate control procedures to monitor the
Drugs
FDA has cleared a Camber Spine Technologies 510(k) for the SPIRA Open Matrix ALIF device, an interbody fusion implant consisting of spiral support arches and the company’s “Surface by Design” technology.“The spiral support arches decrease subsidence by load sharing over the entire endplate, while also maximizing bone
Drugs
Teva and its Barr Laboratories and Watson Laboratories subsidiaries are asking the DC federal court for permission to intervene in Amgen’s suit against FDA over the agency’s refusal to grant the company pediatric exclusivity for its Sensipar (cinacalcet hydrochloride). The generic companies argue that Amgen’s suit, which
Drugs
Lipocine has resubmitted an NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone (hypogonadism). The resubmission addresses issues outlined in a 6/2016 complete response letter and provides additional information related to the dosing algorithm
Drugs
International Laboratories has recalled one lot of pravastatin sodium tablets USP 40 mg packaged in bottles of 30 tablets due to mislabeling. The product is labeled as pravastatin sodium but the lot contained bupropion hydrochloride 300 mg tablets. “If a subject mistakenly takes bupropion, common side effects include: nausea, vomiting,
Drugs
President Trump lashed out at Merck CEO Kenneth Frazier after he resigned 8/14 from the president’s American Manufacturing Council in protest against “intolerance and extremism” in the wake of demonstrations and clashes in Charlottesville, VA. Frazier, who is black, was invited to the White House early after the
Drugs
FDA has lifted a clinical hold against CEL-SCI Corp. and its Phase 3 cancer study with Multikine (leukocyte interleukin, injection), allowing all clinical trial activities under the company’s IND to resume. In June, CEL-SCI responded to FDA about the clinical hold on the Phase 3 head and
Drugs
FDA has told Reata Pharmaceuticals that its modified Friedreich’s Ataxia Rating Scale (mFARS) is an acceptable primary endpoint for Part 2 of the company’s MOXIe trial for omaveloxolone in Friedreich’s ataxia (FA). The rare, degenerative, life-shortening neuro-muscular disorder affects children and adults and involves the
Drugs
Guidance on Medical Device Development Tools Federal Register notice: FDA announces the availability of a guidance on “Qualification of Medical Device Development Tools (MDDT)” that is intended to finalize the MDDT program. 08/10/2017 Guide on Expiry Dating for Unit Dose Repackaging Federal Register notice: FDA announces the availability
Drugs
FDA and Chiasma have reached agreement on a special protocol assessment on the design of a new Phase 3 clinical trial for its octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The study is designed to address agency concerns raised in a previously issued complete
Drugs
FDA has granted Gilead Sciences a priority review for its NDA for an investigational, fixed-dose combination of bictegravir (50mg), an integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25mg), a dual-NRTI backbone, for treating HIV-1 infection. Gilead filed the NDA with a priority review voucher on
Drugs
President Donald Trump says he is declaring the opioid epidemic a national emergency, adding that his administration is drafting paperwork to make it official. The move follows a main recommendation in a 7/31 White House-commissioned interim report that was directed by governor Chris Christie. A final report will
Drugs
FDA has granted Anthera Pharmaceuticals an orphan drug designation for blisibimod for treating immunoglobulin A nephropathy (IgAN). The company says that blisibimod targets B-cell activating factor, which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including IgAN, systemic lupus erythematosus, and others.
Drugs
TherapeuticsMD says it will submit additional endometrial safety information to address the only approvability issue raised in a May-issued complete response letter (CRL) on an NDA for TX-004HR, the company’s investigational applicator-free estradiol vaginal softgel capsule for treating moderate-to-severe vaginal pain during sexual intercourse
Drugs
FDA has posted a guide for physicians seeking to submit requests for non-emergency single-patient expanded access to investigational therapies. According to the guide, such requests begin with a physician obtaining a Letter of Authorization (LOA) from the pharmaceutical company that makes the investigational drug. “A LOA grants the
Drugs
United Therapeutics is suing FDA in DC federal court over the agency’s denial of orphan drug exclusivity for the company’s Orenitram (treprostinil) extended-release tablets to treat pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity. Attorney Kurt Karst (Hyman, Phelps & McNamara) writes in his firm’
Drugs
FDA has issued a safety alert on sterile drug products that are produced and distributed nationwide by Vital Rx Inc. (dba Atlantic Pharmacy and Compounding, Pompano Beach, FL) due to lack of sterility assurance. During a recent inspection of Atlantic Pharmacy, agency investigators observed insanitary conditions, including poor sterile production