US approval of Glenmark’s Clobex shows red flags are not the end of the road for pharma companies
Updated : April 06, 2018 06:32 PM IST
USFDA approved Glenmark’s Clobex spray, the company’s first approval after the regulator issued seven observations to the facility after an inspection conducted in November 2017.
Receiving an approval to manufacture a drug after being issued observations is considered a positive development.
An approval implies the USFDA is most likely okay with the reply by a company to its observations or satisfied with the remedies planned or undertaken at the facility.
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