Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
The approved ANDA is therapeutically equivalent to the reference listed drug product
The approved ANDA is therapeutically equivalent to the reference listed drug product
Application based on results from the TROPION-Breast01 Phase III trial
Vision loss due to Glaucoma can be prevented if it is detected and treated early
The validations confirm the completion of the applications and commence the scientific review process
Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of US $34.7 million in the United States
Diclofenac epolamine topical system 1.3% offers patients a non-opioid topical treatment
Longer-term survival results underscoring role of KEYTRUDA (pembrolizumab) in multiple cancer types, including advanced nonsquamous non-small cell lung cancer (KEYNOTE-189)
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