Lannett Company Inc. of Philadelphia recently obtained and subsequently announced FDA approval of its Abbreviated New Drug Application (ANDA) for Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP) in 2 mg/5 mL dosage form. Read More »
West Pharmaceutical Services Inc. presented on best practices for improving patient outcomes through integrated containment and delivery systems at the Sixth Annual InnoPack Pharma Confex in Mumbai, India. Read More »
A decade-long study of GSK’s Benlysta — the longest to date — recently culminated with indications of the drug’s safety and efficacy against active systemic lupus erythematosus, when administered with standard care. Read More »
Egalet Corp. of Pennsylvania recently obtained a complete response letter from the U.S. Food and Drug Administration about its Oxaydo tablets in 10 mg and 15 mg dosage strengths. Read More »
Janssen Biotech's Darzalex immunotherapy was approved by the U.S. Food and Drug Administration for treating patients with multiple myeloma in combination with pomalidomide and dexamethasone. Read More »
CSL Behring's Haegarda drug, the only subcutaneous therapy for preventing hereditary angioedema attacks in both adolescents and adults, was approved by the U.S. Food and Drug Administration. Read More »
Lannett Company Inc. now has access to “the lion's share of the market” for newly approved dosage strengths of its hydrocodone bitartrate and acetaminophen tablets following recent FDA authorization, according to Lannett CEO Arthur Bedrosian. Read More »
Adapt Pharma recently acknowledged the U.S. Drug Enforcement Administration's new guidance rules for first responders related to the hazards of fentanyl exposure. Read More »
To combat certain types of influenza, Lannett Co. Inc. can now market its Amantadine Hydrochloride Capsules USP in 100 mg. dose form following Food and Drug Administration approval of its Abbreviated New Drug Application. Read More »
Philadelphia-based Lannett Company Inc. recently obtained approval from the U.S. Food and Drug Administration (FDA) for its generic formulation of niacin in extended-release form, with the product available in both 500-mg and 1000-mg tablet doses. Read More »
Drug Channels, a website providing expert insights on pharmaceutical economics and the drug distribution system, recently commented on a new report from the Centers for Medicare & Medicaid Services, titled “Medicare Part D – Direct and Indirect Remuneration.” Read More »
Global generic pharmaceutical giant Teva recently released its generic version of Zetia (ezetimibe) in 10mg tablets to address total and low-density lipoprotein (LDL) blood cholesterol levels for U.S. patients, company officials announced from Jerusalem headquarters. Read More »
After documenting recent product abuse, the U.S. Food and Drug Administration asked Endo Pharmaceuticals to voluntarily remove its reformulated Opana ER (oxymorphone hydrochloride) opioid medication from circulation, stating that risks may now outnumber benefits. Read More »
Express Scripts has released its 2016 Drug Trend Report for the commercial market. Read More »
Fortified with time-release traits, Egalet Corp.’s Guardian tablet has received a U.S. patent, enabling the Pennsylvania-based firm to adapt the medication for potential future products. Read More »
Endo International plc recently announced that one of its operating companies, Endo Pharmaceuticals Inc. based in Malvern, Pennsylvania, is voluntarily recalling one lot of Edex (alprostadil) for injection because the company detected a defect in the crimp caps used in the manufacture of the subject product lot. Read More »
GSK has submitted a supplemental Biologics License Application for Fluarix Quadrivalent (influenza vaccine) to the U.S. Food and Drug Administration. Read More »
Otsuka Pharmaceutical has entered into a licensing agreement that gives it exclusive rights to develop and commercialize Teva Pharmaceutical Industries' migraine prevention drug fremanezumab in Japan. Read More »
Mylan N.V. recently released a statement in response to a Financial Times article entitled “HIV/Aids drug for developing world face threat of disruption.” Read More »
EMED Technologies Corp.'s SCIg60 Infusion System is the first Immune Globulin Subcutaneous (Human) mechanical pump infusion system to be approved by the U.S. Food and Drug Administration. Read More »
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