Cipla gets final approval for generic Dacogen
DSIJ Intelligence / 20 Nov 2017
Pharma major, Cipla has announced that it has received final ANDA approval for decitabine injection 50 mg vial from the USFDA.
Pharma major, Cipla has announced that it has received final ANDA approval for decitabine injection 50 mg vial from the USFDA. With this approval, the company can market the generic version of Otsuka America Pharmaceutical Inc.’s Dacogen in the US market.
The injection is indicated for the treatment of patients with myelodysplastic syndromes (MDS). The product is available for shipping immediately. The US market sales for the product stood at approximately US$180 million for the 12-month period ending September 2017, as per IMS Health.
Earlier, on Saturday, the company received final USFDA approval for the generic equivalent of Pulmicort Respules. The company had filed an ANDA to market Budesonide Inhalation Suspension, 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL, a generic version of AstraZeneca's Pulmicort Respules.
The medications are indicated for the treatment of asthma and as prophylactic therapy in children. The According to IMS Health, the US market sales for the product stood at approximately US$825 million for the 12-month period as on September 2017.
At 11:25 hours on Monday, the stock of Cipla was trading at Rs. 599.55 per share, up by 1.50 per cent. While, S&P BSE Sensex was at 33,339.00 points, down by 0.01 per cent, Nifty50 was at 10,277.40 points, down 0.06 per cent.
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