Shares of Lupin will be in focus after the drugmaker said it has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets in strengths of 40 mg, 80 mg, 120 mg and 160 mg.
The USFDA has tentatively approved the 40 mg and 80 mg strengths as bioequivalent to Xtandi Tablets of Astellas.
While Xtandi tablets are traditionally available in 40 mg and 80 mg strengths, Lupin’s tentatively approved 120 mg and 160 mg strengths will provide healthcare providers and patients with alternative dosing options.
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Earlier in this month, the company launched Azilsartan Medoxomil Tablets, 40mg and 80mg in the United States following the approval from the USFDA.
Also, the company received USFDA approval for its ranibizumab, RanluspecTM (ranibizumab-hkdz) and with its alliance partner Natco Pharma, company received USFDA approval for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials.
In addition, the company announced its strategic collaboration with LABORATORIOS ERN S.A. (ERN), a well-established Spanish pharmaceutical company, for the launch of Luforbec (beclometasone/formoterol) 100/6, a fixed dose combination in a pressurized metered dose inhaler, for the treatment of adult asthma and chronic obstructive pulmonary disease, in Spain.