Two painkillers Tapentadol and Pregabalin may go off OTC over misuse
Alkem's Generic Tapentadol Receives Approval in the U.S.
On Tuesday of last week, Grünenthal initiated a recall of all batches of Palexia® 20 mg/ml oral solution and Palexia® 4 mg/ml oral solution and halted production until further notice due to a bacterial contamination issue. Palexia® tablets are not affected by the contamination and are not being recalled.
The National Commission for Protection of Child Rights has urged the government to stop over-the-counter sale of pain reliever Tapentadol, saying schoolchildren were misusing the drug to get high. The commission has also started framing guidelines for action against substance abuse, a government official said.
Case Name: Grünenthal GmbH v. Alkem Labs. Ltd., 2017-1153, 2017-2048, 2017-2049, 2017-2050, 2019 U.S. App. LEXIS 9187 (Fed. Cir. Mar. 28, 2019) (Circuit Judges Reyna, Taranto, and Chen presiding; Opinion by Reyna) (Appeal from D.N.J., Cecchi, J.)
A little more than two years after first licensing U.S. commercial rights to the Nucynta (tapentadol) pain drug franchise from Depomed Inc., specialty pharma Collegium Pharmaceutical Inc. is acquiring those rights from Depomed successor Assertio Therapeutics Inc. for $375 million in cash, less royalties paid to Assertio in 2020. The deal, which includes both extended-release (ER) and immediate-release formulations of the drug, is expected to close by Feb. 14. It will be financed with $325 million in committed debt financing.
Consumers and health professionals are advised that Seqirus, in consultation with the TGA, is undertaking a product defect correction involving one batch of Palexia 100 mg sustained-release (SR) tapentadol tablets due to a labelling fault.
Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, announced today the closing of its previously announced acquisition of the Nucynta franchise from Assertio Therapeutics, Inc. Jefferies LLC acted as financial advisor to Collegium on the transaction, and Pepper Hamilton LLP served as legal counsel.
LAKE FOREST, Ill., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Assertio Therapeutics, Inc. (“Assertio” or the “Company”) (NASDAQ: ASRT), today announced it has entered into a definitive agreement (“Agreement”) with Collegium Pharmaceutical, Inc. (“Collegium”) pursuant to which Collegium will acquire the NUCYNTA® franchise of products from the Company. The closing of the agreement is expected by February 14, 2020.
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