Generics

Elite Pharmaceuticals files ANDA for generic opiate analgesic product
The FDA accepted for review Elite's undisclosed generic drug product in a class of medications called opiate analgesics.
Rising Pharmaceuticals opens new manufacturing facility
The Decatur, Ill.-based facility expands the company’s sterile dosage capabilities, which includes injectables and ophthalmics.

Aurobindo receives FDA nod for generic Librax

Generic Librax is used to control certain emotional and somatic factors in gastrointestinal disorders.
Alembic intros generic Brovana

Arformoterol Tartrate Inhalation Solution is indicated for long-term, twice-daily administration in the maintenance treatment of bronchoconstriction in patients with COPD.
Novartis shareholders give green light to Sandoz generics business spin-off

Novartis shareholders have approved the proposed 100% spin-off of Sandoz, the generics and biosimilars business of Novartis.
Alembic debuts generic Bepreve

Bepotastine Besilate Ophthalmic Solution is a histamine H receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Aurobindo receives FDA OK for 2 generics

Aurobindo has obtained the FDA's nod for generic Prolixin and generic Imodium.
Strides Pharma receives FDA nod for generic Renvela

Sevelamer Carbonate for Oral Suspension is a medication used to manage elevated levels of phosphate in the blood of patients with chronic kidney disease.
Lupin partners with Mark Cuban Cost Plus Drug Company, COPD Foundation to expand medication access

Lupin’s Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, is the only generic product available that is therapeutically equivalent to Boehringer Ingelheim’s Spiriva HandiHaler.
Amneal obtains FDA OK for calcium gluconate injection

Calcium gluconate in sodium chloride injection is a small volume parenteral bag indicated for the treatment of acute symptomatic hypocalcemia in pediatric and adult patients.

Elite Pharmaceuticals files ANDA for generic opiate analgesic product

Rising Pharmaceuticals opens new manufacturing facility

Aurobindo receives FDA nod for generic Librax

Alembic intros generic Brovana

Novartis shareholders give green light to Sandoz generics business spin-off

Alembic debuts generic Bepreve

Aurobindo receives FDA OK for 2 generics

Strides Pharma receives FDA nod for generic Renvela

Lupin partners with Mark Cuban Cost Plus Drug Company, COPD Foundation to expand medication access

Amneal obtains FDA OK for calcium gluconate injection