Containment FDA Approval Generic Drugs Marketing 
The Pharma Data
MARCH 15, 2022
Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.
Camargo
DECEMBER 9, 2020
If you are facing an FDA remote review, Camargo can help design a comprehensive approach in order to avoid such pitfalls. Approval of the Month: Alnylam to Use Value-Based Agreements for Ultra-rare Disease Treatment. Evergreening Orphan Drugs May Be Over. Without that showing, the FDA is directed to revoke the exclusivity.
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Camargo
NOVEMBER 11, 2020
When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Prior to the availability of this test, Bayer struggled to find patients for its new drug.
Delveinsight
FEBRUARY 5, 2021
According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products.
FDA Law Blog
MARCH 13, 2024
156(d)(l)(D) requires that a PTE application contain “a brief description of the activities undertaken by the applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities” In addition, 35 U.S.C. § How, pray tell, does this relate to PTEs you ask?
The Pharma Data
DECEMBER 28, 2020
Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. This market information is based on IQVIA data for the 12 months ended September 30, 2020.
Pharmacy Checkers
NOVEMBER 21, 2019
The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. There are 19,000 approved prescription drugs for marketing in the U.S. Just because those products have been approved doesn’t mean FDA’s work is done.
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