FDA Authorizes Generic Lurasidone Hydrochloride Tablets – APhA submits compounding comments to FDA.

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FDA Authorizes Generic Lurasidone Hydrochloride Tablets – APhA submits compounding comments to FDA. – (866) 348-2889.

The FDA has approved marketing of Lupin Pharmaceuticals’ Lurasidone Hydrochloride Tablets, a generic version of Sunovion Pharmaceuticals, Inc’s lurasidone HCl (Latuda) tablets, according to the company. Both products are approved for 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.

According to Lupin’s announcement, its Lurasidone Hydrochloride Tablets are indicated for treatment of adult patients with schizophrenia, monotherapy treatment of adult patients with major depressive episode associated with bipolar I disorder, and adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder.

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Lupin Recalls 42 Lots of Ceftriaxone for Injection – Drug for nerve pain boosts high for opioid abusers.

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Lupin Recalls 42 Lots of Ceftriaxone for Injection – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Lupin Pharmaceuticals, Inc. has voluntarily recalled 42 of lots of Ceftriaxone for Injection, USP products at the hospital/physician level. These products were found to contain visual grey particulate matter in reconstituted vials.

Ceftriaxone for Injection, USP, is used as a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. It is used to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone sodium and other antibacterial drugs. The Lupin recall includes 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g;  and 3 lots of Ceftriaxone for Injection, USP 2g.

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FDA approved a record number of drugs in 2018 – APhA submits compounding comments to FDA.

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FDA approved a record number of drugs in 2018 – APhA submits compounding comments to FDA. – (866) 348-2889.

FDA drug approvals hit an all-time high in 2018, with 59 new molecular entities securing the agency’s permission to head to market. Small molecules comprised 64% of therapies approved in 2018, while antibodies represented 20% of approvals. With 15% of new drugs falling outside of those two main modalities, the list also reflects the increasingly diverse approaches researchers are using to take down diseases—particularly rare, genetic diseases. The 2018 class also brought treatments for long-underserved diseases, including a new class of drug for migraine prevention, the first new drug for endometriosis in over a decade, and the first marijuana-extracted treatment for a rare form of epilepsy.

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Recall Expanded for Losartan Potassium Tablets – Drug for nerve pain boosts high for opioid abusers.

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Recall Expanded for Losartan Potassium Tablets – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

A recall of Torrent Pharmaceuticals Limited’s Losartan Potassium Tablets USP has been expanded to include 8 additional lots. A total of 10 lots are now being recalled at the consumer level, including 2 recalled lots initially announced December 20, 2018.

Torrent’s products are being recalled due to the detection of trace amounts of N-nitrosodiethylamine (NDEA), an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Since July, multiple companies have voluntarily recalled products containing valsartan, irbesartan, and losartan, stemming from concerns about NDEA levels. Earlier this week, Aurobindo Pharma USA announced it was voluntarily recalling 80 lots of valsartan tablets.

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Dasatinib Approved for Treatment of Certain Pediatric Patients – APhA submits compounding comments to FDA.

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Dasatinib Approved for Treatment of Certain Pediatric Patients – APhA submits compounding comments to FDA. – (866) 348-2889.

The FDA has approved dasatinib (Sprycel, Briston-Myers Squibb) tablets in combination with chemotherapy for the treatment of pediatric patients ≥1 year of age with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

The approval was based on findings from a single cohort of the phase II CA180-372 trial (NCT01460160), which demonstrated a 3-year event-free survival (EFS) binary rate of 64.1% (95% CI, 52.4%-74.7%) in 78 pediatric patients with newly diagnosed B-cell precursor Ph+ ALL.

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Large-Scale Commercial Production Approved for Factor Xa Inhibition Reversal Agent – Drug for nerve pain boosts high for opioid abusers.

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Large-Scale Commercial Production Approved for Factor Xa Inhibition Reversal Agent – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA approved Portola Pharmaceuticals’ Prior Approval Supplement (PAS) for the Generation 2 manufacturing process for Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], according to a press release.1

This approval allows full commercial launch for Andexxa, which was previously launched under an Early Supply Program with Generation 1 product. The new Generation 2 manufacturing process will enable it to scale up production and stock hospitals nationwide, according to the company.

Andexxa originally received regulatory approval in May 2018 under the FDA’s Accelerated Approval pathway as the first antidote indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

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Study: Genetic Risk Variant Linked to Astrocytes Increases Risk of MS – APhA submits compounding comments to FDA.

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Study: Genetic Risk Variant Linked to Astrocytes Increases Risk of MS – APhA submits compounding comments to FDA. – (866) 348-2889.

A genetic risk variant, rs7665090G, located near NFKB1, on astrocytes enhances the accessibility of the central nervous system (CNS) to peripheral immune cells, escalating the risk of autoimmune inflammation and multiple sclerosis (MS), according to the results of a recent study.

One recent finding suggested that changes in immune enhancers such as lymphocytes may disrupt innate and adaptive immune pathways; however, investigators were still unsure whether they affected CNS function and thus increased MS risk. In this study, rs7665090G was used to determine whether dysregulation in astrocyte function will affect MS risk.

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FDA warns of increased risk of ruptures or tears in the aorta with fluoroquinolone antibiotics in certain patients – Drug for nerve pain boosts high for opioid abusers.

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FDA warns of increased risk of ruptures or tears in the aorta with fluoroquinolone antibiotics in certain patients – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

FDA cautioned Thursday that fluoroquinolone antibiotics may increase the risk of rare but serious events of ruptures or tears in the aorta. The tears, known as aortic dissections, or ruptures of an aortic aneurysm, can lead to serious bleeding or even death. According to FDA, “Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available. People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly.” A new warning about this risk must be added to the prescribing information and patient Medication Guide for all fluoroquinolones, FDA said. The agency’s warning is based on cases reported to FDA and four published observational studies that indicated a higher risk of aortic aneurysm or dissection associated with fluoroquinolone use.

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IDSA Updates Guidelines on Flu Diagnosis and Response – APhA submits compounding comments to FDA.

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IDSA Updates Guidelines on Flu Diagnosis and Response – APhA submits compounding comments to FDA. – (866) 348-2889.

Outpatients who have been diagnosed with influenza and are at high risk for complications, particularly pregnant women and the extremely obese, should be provided antiviral treatment as soon as possible, note updated seasonal influenza guidelines from the Infectious Diseases Society of America (IDSA).

The guidelines recommend using molecular tests that deliver results in 15-60 minutes instead of rapid-influenza diagnostic tests (RIDTs), which produce quick results but can be falsely negative in at least 30% of outpatients with influenza. While antiviral treatment is recommended within 2 days after the start of flu symptoms in people who aren’t at high risk for complications, the guidelines note they should be prescribed to those at high risk even if they have been sick for more than 2 days.

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FDA OKs Pediatric Hexavalent Combination Vaccine – Drug for nerve pain boosts high for opioid abusers.

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FDA OKs Pediatric Hexavalent Combination Vaccine – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the US FDA have approved a vaccine for use in children younger than age 5 that is indicated for immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (Vaxelis™).

Developed as part of a joint partnership between Sanofi and Merck, the companies are working to maximize production of the vaccine to allow for a sustainable supply to meet anticipated  demand, but commercial supply is not expected until 2020. The vaccine is approved for use as a 3-dose series, which consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age. This vaccine does not constitute a primary immunization series against pertussis.

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