Skip to main content

Generics

  • FDA approves Teligent’s triamcinolone acetonide ointment
    SILVER SPRING, Md. — The Food and Drug Administration has approved Teligent Pharmaceuticals’ triamcinolone acetonide ointment (USP, 0.1%), the company announced Monday. 
     
    The ointment is indicated to treat skin inflammation, itching, dryness and redness. According to IMS Health, the product has and estimated market size of $24 million. Teligent expects to launch the ointment in the second quarter of 2015, and it will be available in 15- and 80-gram tubes, as well as a one-pound jar. 
     

  • McKesson, Walmart team on generics sourcing, extend distribution agreement
    SAN FRANCISCO and BENTONVILLE, Ark. — McKesson and Walmart announced a new generics sourcing agreement Monday alongside and extended distribution contract between the two companies. In a move aimed at improving value and scale for both parties, the agreement will see Walmart and McKesson jointly sourcing generics for their U.S. operations. 
     

  • FDA warns of serious side effects from certain antibiotics
    SILVER SPRING, Md. — The Food and Drug Administration issued a safety message late last week concerning the potential for serious side effects associated with fluoroquinolone antibiotics. 
     

  • MD Labs' Rxight advances President's Precision Medicine Initiative
    WASHINGTON – In an effort to expand upon President Barack Obama’s Precision Medicine Initiative and explore innovative ways to individualize patient care, representatives from MD Labs recently met with senior leadership at the White House Office of Science and Technology Policy.
     

  • Mylan to acquire Renaissance’s specialty, generics businesses
    PITTSBURGH — Mylan on Thursday announced the planned acquisition of Renaissance Acquisition Holdings’ specialty and generics businesses, which are focused on topical treatments. The deal will see Mylan paying $950 million in cash at closing, as well as additional contingent payments up to $50 million based on customary adjustments. 
     

  • 70 groups pen letter to FDA on biosimilar naming
    SILVER SPRING, Md. — A group of 70 healthcare stakeholders sent a letter to the Food and Drug Administration this week, urging the agency to use meaningful, distinguishable suffixes when naming biosimilars. According to the Alliance for Safe Biologic Medicines, the letter was spurred by the agency choosing a random suffix when it approved the second biosimilar earlier this year. 
     

  • Mylan launches generic Frova
    PITTSBURGH — Mylan on Thursday announced the launch of its generic Frova (frovatriptan succinate) tablets. The drug is indicated to treat acute migraine headaches in adults. 
     
    Mylan’s tablets will be available in 2.5-mg dosage strength. The product had U.S. sales of $88.3 million for the 12 months ended March 31, according to IMS Health. 
     

  • FDA approves Aurobindo’s generic Opana
    Dayton, N.J. — Aurobindo Pharma on Thursday announced that it had received final approval from the Food and Drug Administration for its generic Opana (oxymorphone HCl) tablets. The drug is indicated to help relieve moderate to severe pain in patients whose doctors have deemed the use of an opioid appropriate. 
     
    The drug will be available in 5- and 10-mg dosage strengths and IMS Health has estimated it market size to be about $103.1 million for the 12 months ended March 2016.  
     
X
This ad will auto-close in 10 seconds